Ansell CE4-200 Microflex Cleanroom Latex Gloves Class 10 (ISO 4)

Ansell MICROFLEX CE4-200 ISO Class 4 Nonsterile Cleanroom Latex Gloves

Ansell MICROFLEX™ CE4-200 is a powder-free, nonsterile natural rubber latex glove designed for Class 10 (ISO Class 4) cleanroom environments. Manufactured using an ultra-clean processing approach, CE4-200 combines low surface particle levels, controlled ionic extractables, and low nonvolatile residues with the flexibility and tactile sensitivity of natural rubber latex.

CE4-200 features an ambidextrous design, a beaded cuff, and a 12-inch (300 mm) glove length to provide extended wrist and lower forearm coverage. Its cleanroom-oriented packaging contains 100 gloves per inner polybag, with 10 inner polybags per lined carton, totaling 1,000 gloves per case.

The gloves are suitable for evaluation in pharmaceutical manufacturing, biotechnology, medical device manufacturing, electronics assembly, and other contamination-sensitive operations where the facility permits nonsterile latex gloves and requires documented cleanroom compatibility.

• Manufacturer: Ansell
• Brand: MICROFLEX™
• Manufacturer Model: CE4-200
• Product Type: Nonsterile disposable cleanroom latex glove
• Cleanroom Classification: Class 10 / ISO Class 4 compatible, per Ansell
• Material: Natural rubber latex
• Color: Natural
• Shape: Ambidextrous
• Cuff Style: Beaded
• Glove Length: 300 mm (12") typical
• Palm Thickness: 0.14 mm (5.5 mil) target single-wall thickness
• Finger Thickness: 0.18 mm (7.1 mil) target single-wall thickness
• Cuff Thickness: 0.11 mm (4.3 mil) target single-wall thickness
• Thickness Test References: EN 420 / ASTM D3767
• Freedom from Holes: 1.5 AQL
• AQL Test References: EN 455-1 / ASTM D3577, as identified by the manufacturer
• Particle Count: Fewer than 850 particles/cm² for particles measuring 0.5 µm and larger
• Particle Test Method: IEST-RP-CC005.4, per the manufacturer's technical table
• Cleanliness Processing: Ultra-clean processed to reduce particulates, ionic extractables, and nonvolatile residues
• Powder Content: Powder-free
• Internal Glove Surface: Powder-free
• Sterile: No
• Antistatic: No
• Chemotherapy Drug Testing: No
• Available Sizes: XS, S, M, L, XL
• Packaging: 100 gloves per inner polybag; 10 inner polybags per lined carton
• Case Quantity: 1,000 gloves
• Manufacturer-Published Shelf Life: 3 years, subject to applicable storage conditions and lot labeling
• Published Quality-System References: EN 420:2003 + A1:2009, ISO 13485, ISO 9001
• Primary Applications: Cleanroom preparation, material transfer, equipment handling, weighing, dispensing, and component assembly

Specification qualification: Manufacturer-published physical and cleanliness measurements describe the product under identified test methods. Customers with controlled particle, ionic, residue, or sterility requirements should confirm the current manufacturer specification and any necessary lot documentation before qualifying the glove for a particular process.

Ansell is a global manufacturer of personal protective equipment and specialized hand protection products serving healthcare, life sciences, semiconductor manufacturing, biotechnology, pharmaceutical production, and industrial markets. Its cleanroom glove portfolio includes both sterile and nonsterile products designed to address different contamination-control and operator-protection requirements.

MICROFLEX™ CE4-200 is designed for cleanroom operations where particulate and chemical residue control are important. Ansell describes the product as ultra-clean processed, supporting low surface particulates, low ionic extractables, and low nonvolatile residue levels while retaining the elasticity and tactile characteristics of natural rubber latex.

SOSCleanroom provides specialty cleanroom gloves and contamination-control supplies for pharmaceutical, biotechnology, medical device, electronics, and laboratory customers. Our team assists with product selection, manufacturer documentation, size-specific purchasing, and recurring cleanroom supply requirements.

• Class 10 / ISO Class 4 cleanroom-compatible design
• Ultra-clean processed natural rubber latex construction
• Powder-free internal glove surface
• Low particulate and ionic contamination characteristics
• Manufacturer-published nonvolatile residue control
• Fewer than 850 particles/cm² at particle sizes of 0.5 µm and larger, under the published test method
• 300 mm (12") overall glove length
• Ambidextrous shape
• Beaded cuff for handling and positioning
• 1.5 AQL freedom-from-holes classification
• Natural latex elasticity for tactile control and dexterity
• Cleanroom-oriented inner polybag packaging
• Nonsterile configuration
• Three-year manufacturer-published shelf life
• 1,000 gloves per lined carton

• Cleanroom compatibility: Designed for Class 10 / ISO Class 4 controlled environments where glove cleanliness is part of the overall contamination-control strategy.
• Reduced particulate contribution: Ultra-clean processing supports low surface particle levels under the manufacturer's published testing method.
• Ionic residue control: Published ionic extractable data helps quality teams evaluate potential glove-related ionic contamination.
• Low nonvolatile residues: The manufacturer positions CE4-200 for applications requiring attention to chemical residue backgrounds.
• Extended coverage: The 12-inch length provides additional wrist and lower forearm coverage for cleanroom gowning interfaces.
• Tactile sensitivity: Natural latex elasticity supports precision handling of instruments, components, and laboratory materials.
• Powder-free construction: Avoids intentionally added glove powder that can contribute to contamination.
• Documented packaging: Inner polybags and a lined carton support controlled transfer planning and product identification.
• Procurement consistency: Defined glove sizes, carton quantities, and manufacturer cleanliness data assist with standardization.

ISO Class 4 is an airborne particle cleanliness classification for controlled environments. The classification of the room is separate from the particle cleanliness characteristics of the gloves, garments, and other consumables used inside it.

Ansell identifies MICROFLEX CE4-200 as designed to be compatible with Class 10 (ISO Class 4) cleanroom environments. The manufacturer reports a typical particle count below 850 particles/cm² for particles measuring 0.5 µm and larger, using IEST-RP-CC005.4.

• Cleanroom positioning: Class 10 / ISO Class 4 compatible, as stated by Ansell.
• Measured cleanliness characteristic: Surface particles measuring 0.5 µm and larger.
• Published particle result: Fewer than 850 particles per cm² under the identified test method.
• Testing methodology: IEST-RP-CC005.4, as shown in the manufacturer's technical table.
• Particle size threshold: The published result does not describe every possible particle size or all particle-generation conditions during glove use.
• Process-specific cleanliness: Glove suitability depends on facility requirements for particles, residues, packaging, gowning, and material handling.
• Lot qualification: Customers requiring controlled acceptance data should obtain the applicable manufacturer certificate or approved lot documentation.

Important distinction: Cleanroom-compatible does not mean particle-free, sterile, or qualified for every ISO Class 4 manufacturing operation. The facility's contamination-control program must establish how the published glove cleanliness performance relates to the actual process.

Ionic contamination can be important in semiconductor processing, electronics assembly, medical device manufacturing, and other sensitive applications. Gloves can transfer ionic substances to components or process surfaces through direct contact.

Ansell publishes typical ionic content values for CE4-200 to help customers assess its cleanliness characteristics. These values represent the manufacturer's reported measurements under specified conditions and should not be treated as universal guarantees for every individual glove.

• Chloride: Less than 1.00 µg/cm²
• Sodium: Less than 0.20 µg/cm²
• Calcium: Less than 0.50 µg/cm²
• Potassium: Less than 0.20 µg/cm²
• Bromide: Less than 0.20 µg/cm²
• Sulphate: Less than 0.20 µg/cm²
• Magnesium: Less than 0.03 µg/cm²
• Nitrate: Less than 0.50 µg/cm²
• Phosphate: Less than 0.20 µg/cm²
• Fluoride: Less than 0.20 µg/cm²

Selection guidance: When contamination limits are critical, compare the manufacturer's ionic and residue measurements against the facility's documented acceptance criteria. Separate qualification may be required for nonvolatile residues, organic contaminants, surface transfer, and process-specific materials.

A glove can be manufactured and processed for a high-cleanliness environment without being sterile. CE4-200 is an example of a cleanroom-oriented glove specifically designated by Ansell as nonsterile.

For nonsterile controlled manufacturing, cleanliness requirements may emphasize surface particles, extractables, and process compatibility. Critical aseptic operations have additional microbial contamination-control requirements that may necessitate sterilized gloves and validated sterile packaging.

• CE4-200: Nonsterile latex glove designed for Class 10 / ISO Class 4 cleanroom compatibility.
• Cleanroom cleanliness: Manufacturer-published particle and ionic information supports evaluation of nonviable contamination.
• Sterile gloves: Require documented sterilization, appropriate packaging, and applicable sterility assurance information.
• Aseptic manipulation: Critical operations requiring sterile gloves must use a separately qualified sterile product.
• Gowning procedure: The facility must establish how gloves are introduced, donned, disinfected where permitted, and changed during operations.
• Disinfection limitation: Wiping or spraying a nonsterile glove with disinfectant does not automatically make the glove sterile.
• Product compatibility: The glove must be evaluated for the facility's disinfectants, process chemicals, and expected contact conditions.

CE4-200 is manufactured from natural rubber latex. Although latex provides elasticity, comfort, and tactile response, it contains proteins that may cause allergic reactions in sensitized individuals.

The cleanroom processing and powder-free construction of CE4-200 do not eliminate the risk of Type I latex allergy. The glove also lacks a manufacturer antistatic designation, which is important when selecting PPE for electrostatic discharge-sensitive environments.

• Natural rubber latex: Contains proteins capable of causing allergic reactions.
• Type I hypersensitivity: May produce immediate reactions in sensitized users.
• Latex-restricted facilities: Use a suitably qualified latex-free alternative when natural rubber latex is prohibited.
• Powder-free: Reduces an intentionally added contamination source but does not establish latex allergen safety.
• Antistatic: Ansell identifies CE4-200 as not antistatic.
• ESD-controlled operations: Use gloves with documented electrostatic performance appropriate to the facility's requirements.
• Electronics manufacturing: Cleanroom cleanliness alone does not qualify the product for static-sensitive component handling.
• Chemotherapy protection: Ansell does not identify CE4-200 as tested for chemotherapy drug use.

Selection guidance: Choose gloves based on all applicable hazards. Particle cleanliness, material allergy compatibility, chemical resistance, electrostatic properties, and sterility must each be evaluated independently.

CE4-200 has a nominal length of 300 mm (12"), offering extended wrist and lower forearm coverage for cleanroom operations. Proper glove-to-sleeve overlap is important in controlling exposed skin and reducing contamination transfer.

• Glove fit: Select the correct size to reduce excessive stretching, loose fingertips, and handling difficulties.
• Clean hands: Follow the facility's hand hygiene procedure and ensure hands are appropriately dry before donning.
• Packaging entry: Introduce glove packages through the approved material transfer procedure.
• Controlled opening: Open inner packaging at the designated gowning or point-of-use location according to the facility SOP.
• Cuff positioning: Maintain the required overlap between glove cuffs and gown sleeves.
• Exposed skin: Avoid creating gaps at the wrist during reaching, stretching, or repeated hand movements.
• Outer-surface contact: Minimize contact between the glove exterior and uncontrolled surfaces.
• Glove changes: Replace gloves according to procedural intervals and after contamination, damage, or suspected integrity loss.
• Disinfection: Use only methods and chemical products approved for the glove material and the specific process.
• Aseptic restrictions: Do not use a nonsterile glove in procedures requiring sterile glove presentation.

Gowning guidance: The correct placement of gloves over or under garment sleeves depends on the facility's validated gowning procedure. A 12-inch glove length supports additional coverage but does not automatically ensure a contamination-tight interface.

Ansell publishes a cleanroom-oriented packaging configuration for CE4-200 consisting of inner polybags and a lined outer carton. This packaging arrangement can support controlled material introduction when handled according to facility procedures.

• Inner packaging: 100 gloves per inner polybag.
• Outer packaging: 10 inner polybags per lined carton.
• Case quantity: 1,000 gloves per carton.
• Receiving: Inspect the carton and inner packages for damage or evidence of contamination.
• Material transfer: Follow approved procedures for removing external packaging before entering more critical areas.
• Package opening: Prevent contact between clean glove surfaces and uncontrolled packaging or work surfaces.
• Traceability: Retain manufacturer part numbers and lot information when required by the facility quality system.
• Repackaging: Avoid uncontrolled repackaging that could compromise the intended cleanliness characteristics.

Packaging distinction: Cleanroom-oriented packaging is not proof of sterile packaging. The manufacturer's current published configuration should be verified against the received product and any controlled packaging specifications.

• Nonsterile Class 10 / ISO Class 4 cleanroom operations
• Cleanroom cleaning and preparation
• Controlled transfer of compatible liquids and solids
• Weighing and dispensing raw materials
• Laboratory equipment and instrument handling
• Loading centrifuges and chromatography columns
• Blending and compounding compatible materials
• Component inspection and precision assembly
• Medical device manufacturing processes where nonsterile gloves are permitted
• Biotechnology and pharmaceutical manufacturing support
• Electronics and microelectronics operations where the absence of antistatic qualification is acceptable
• Contamination-sensitive material handling requiring low surface particles and controlled ionic residues

Application limitation: These applications require evaluation of the process, room classification, chemical hazards, glove cleanliness, latex sensitivity, and sterility requirements. The ISO 4 compatibility statement does not establish suitability for every operation performed within an ISO Class 4 room.

• Verify latex acceptability: Confirm that natural rubber latex is permitted for personnel and the work environment.
• Confirm cleanroom requirements: Ensure that the nonsterile ISO Class 4 glove configuration meets the facility's qualification criteria.
• Choose the correct size: Select gloves that allow dexterity without excessive stretching or loose material.
• Inspect the packaging: Check for tears, punctures, moisture intrusion, and damaged seals before use.
• Follow the gowning SOP: Open the packaging and don gloves at the approved stage of the gowning sequence.
• Use clean, dry hands: Follow hand hygiene requirements before donning.
• Maintain sleeve overlap: Position the 12-inch glove cuff as required by the approved gowning procedure.
• Avoid uncontrolled contact: Do not touch unqualified surfaces and then return to critical work without the required glove change.
• Check compatibility: Verify that solvents, cleaning agents, and process chemicals are suitable for natural rubber latex.
• Replace damaged gloves: Change immediately after tearing, puncture, contamination, or suspected integrity loss.
• Control residue transfer: Change gloves when moving between materials or processes with different contamination requirements.
• Doff carefully: Remove gloves according to the facility's contamination-control procedure.
• Dispose appropriately: Follow applicable laboratory, process, and waste-management requirements.

Ansell publishes a three-year shelf life for CE4-200. Storage and handling can affect natural latex properties and the integrity of protective packaging. Customers should follow the manufacturer instructions and the expiration or lot information associated with the received product.

• Shelf life: 3 years, per the manufacturer technical sheet.
• Storage environment: Store in a cool, dry location according to applicable manufacturer instructions.
• Direct sunlight: Protect latex gloves from prolonged direct sunlight.
• Ozone exposure: Keep away from sources of ozone that can affect natural rubber materials.
• Heat and ignition: Avoid storage conditions that may accelerate material deterioration.
• Package integrity: Keep inner polybags protected until required for controlled use.
• Lot rotation: Apply the facility's first-expiring-first-out policy when appropriate.
• Receiving checks: Verify the exact size, manufacturer part number, lot identification, and expiration information.
• Product condition: Do not use gloves showing tackiness, cracking, tears, discoloration, or other signs of deterioration.

Availability information: Ordering lead times and availability are subject to confirmation at the time of purchase. Contact SOSCleanroom for current size-specific availability when scheduling critical production requirements.

Ansell identifies five standard CE4-200 sizes. All are listed with the same 100-glove inner polybag and 1,000-glove carton configuration.

• Extra Small (XS), 5.5–6: CE4-200-XS
• Small (S), 6.5–7: CE4-200-S
• Medium (M), 7.5–8: CE4-200-M
• Large (L), 8.5–9: CE4-200-L
• Extra Large (XL), 9.5–10: CE4-200-XL

Ordering guidance: Confirm glove size and the 1,000-glove case configuration before placing recurring, blanket, or controlled purchasing orders. Use the exact manufacturer part number to avoid substituting an examination latex glove, sterile latex glove, or glove with a different cleanroom cleanliness specification.

• CE4-200 vs. Ansell AccuTech 91-225: CE4-200 is a nonsterile latex glove designed for Class 10 / ISO 4 compatibility. AccuTech 91-225 is a sterile latex cleanroom glove designed for different aseptic protection requirements and associated with ISO Class 5. Sterility and cleanliness must be evaluated separately.
• CE4-200 vs. Ansell Nitrilite 93-311: Nitrilite 93-311 provides a synthetic nitrile alternative for cleanroom applications with different material and cleanliness specifications. Evaluate chemical resistance, particle performance, and latex restrictions before substitution.
• Nonsterile vs. sterile latex: For critical aseptic processing, use an appropriately documented sterile glove rather than relying on the ISO Class 4 compatibility of CE4-200.
• Latex vs. nitrile: Natural latex offers elasticity and tactile response, while nitrile avoids natural rubber latex proteins and has different chemical resistance characteristics.
• Cleanroom vs. general examination gloves: Standard examination gloves should not be treated as equivalent to cleanroom-processed gloves without supporting cleanliness data.
• Non-antistatic vs. ESD-qualified gloves: CE4-200 is not antistatic. Use an appropriately tested glove when electrostatic performance is a critical process requirement.

Sterile Latex Cleanroom Gloves

• Ansell AccuTech 91-225: Sterile natural rubber latex cleanroom gloves for compatible aseptic and sterile manufacturing processes requiring a different sterility and cleanliness configuration.

Cleanroom Nitrile Glove Alternative

• Ansell Nitrilite 93-311: Nonsterile synthetic nitrile cleanroom gloves for selected Class 100 / ISO Class 5 controlled-environment applications where natural rubber latex must be avoided.

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