The Technical Vault
By SOSCleanroom
ISO 4 (Class 10)
Natural rubber latex
Powder-free
Non-sterile
12 in / 300 mm length
Ansell MICROFLEX® CE4-200 Cleanroom Latex Gloves (Non-Sterile) — ISO 4/Class 10 Hand Protection With Published Particle and Ionic Background
Product shown: MICROFLEX® CE4-200 (SKU CE4-200) — cleanroom-compatible latex glove for ISO 4/Class 10 areas.
1) Practical solutions in a critical environment
In ISO 4 / Class 10 work, your glove is part of the contamination-control system — not just PPE. The CE4-200 is built for controlled environments where teams want a comfortable latex glove but still need measurable background indicators (typical particle count and typical ionic extractables) to support incoming-material qualification, stable “blank” conditions, and repeatable handling outcomes on sensitive parts, tools, and surfaces.
2) What it’s for in ISO 4 workflows
CE4-200 is commonly selected for cleanroom activities where tactility and comfort matter, but contamination risk still needs managed:
- Cleanroom cleaning and preparing tasks where glove-to-surface contact is frequent.
- Blending/compounding and handling of solids and liquids where grip and dexterity reduce drop/impact events.
- Transfer and assembly tasks where touch-control and repeatable finger movement reduces handling variability.
- Lab and electronics handling where published ionic background helps teams plan residue-sensitive work.
3) Why should customers consider this glove
- Designed for ISO 4 (Class 10) compatibility: selection intent aligns to critical environments where background control is part of the process.
- Published cleanliness context: typical particle count and typical ionic extractables support qualification logic and change-control discussions.
- Powder-free internal surface: reduces powder-related contamination pathways compared with powdered gloves (operator and process dependent).
- Comfort + tactility from latex formulation: strong fit/feel can reduce over-gripping, which is a common driver for tears and dropped parts.
- Audit-friendly packaging description: published case configuration supports receiving inspection and line-side presentation planning.
Latex caution (important): This glove contains natural rubber latex. Latex may cause allergic reactions in some users. Safe use by or on latex-sensitized individuals has not been established. If latex sensitivity is a concern, consider a nitrile alternative in the same ISO class (see “Closest competitors”).
4) Materials and construction
CE4-200 is a non-sterile, disposable natural rubber latex glove with a beaded cuff, ambidextrous shape, and powder-free internal surface. It is produced in an integrated facility (ISO 9001 referenced) and processed to reduce surface particulates, ionic extractables, and non-volatile residues for controlled-environment handling.
5) Specifications in context
These published specifications are most useful when you tie them to your real task mechanics: pinch force, wet handling, glove-change cadence, and the sensitivity of the items being touched (optics, coated parts, assemblies, sterile barriers, or analytical sampling).
| Cleanroom class |
Class 10 / ISO 4 |
| Length (typical) |
300 mm / 12 in |
| Freedom from holes (AQL) |
1.5 AQL (Inspection Level I) |
| Thickness (single-wall targets) |
Finger: 0.18 mm (7.1 mil) | Palm: 0.14 mm (5.5 mil) | Cuff: 0.11 mm (4.3 mil)
|
| Antistatic |
No |
| Sterility |
Non-sterile |
| Shelf life (published) |
3 years |
6) Cleanliness and contamination metrics
In ISO 4 work, “clean” needs numbers behind it. Use the metrics below as planning context (typical values) and align acceptance criteria to your CCS and site qualification approach.
Typical particle count (glove surface)
| Metric |
Published typical value |
Test reference |
| Particles ≥ 0.5 µm (counts/cm²) |
< 850 counts/cm² |
IEST-RP-CC005.4 (method referenced) |
Typical ionic extractables (surface) (units shown as µg/cm²)
| Ion |
Published typical concentration (µg/cm²) |
Ion |
Published typical concentration (µg/cm²) |
| Bromide |
< 0.20 |
Nitrate |
< 0.50 |
| Calcium |
< 0.50 |
Phosphate |
< 0.20 |
| Chloride |
< 1.00 |
Potassium |
< 0.20 |
| Fluoride |
< 0.20 |
Sodium |
< 0.20 |
| Magnesium |
< 0.03 |
Sulphate |
< 0.20 |
Typical NVR: Not published in the referenced CE4-200 product data sheet.
7) Packaging, sterility, and traceability
- Pack configuration (published): 10 polybags per 1 master bag; 1 master polybag per case; 100 gloves per double polybag (case quantity: 1,000 gloves).
- Sterility: Non-sterile. If your process requires sterile glove presentation inside a sterile field, qualify a sterile alternative per your CCS and aseptic gowning SOP.
- Sizing (published): XS (5.5–6), S (6.5–7), M (7.5–8), L (8.5–9), XL (9.5–10).
- Receiving/traceability tip: In ISO 4 programs, treat glove cases as controlled consumables. Record lot/date identifiers per your site practice, and segregate opened cases from unopened inventory to reduce handling drift.
8) Best-practice use
Operator-level handling that pays off in ISO 4:
- Donning discipline: Don in a controlled area, avoid contact with cartons and non-controlled surfaces, and seat the beaded cuff fully to reduce roll-down and sleeve-gap formation.
- Glove-change triggers: Define change triggers by task (wet work, solvent contact, visible residue, touch of non-controlled surface, or time-in-use). ISO 4 programs typically benefit from more frequent changes than “comfort-driven” changes.
- Pinch-force management: Most glove tears occur during high pinch force (cap removal, small fasteners, tool edges). Use tools/fixtures to reduce pinch where practical.
- Wipe-wet work: If you are handling IPA/disinfectants, control drip paths at cuffs and benches. Wet cuffs can transfer residues quickly and create “clean-looking” contamination.
- Residue-sensitive handling: When blanks/background matter (optics, coated parts, analytical work), avoid touching glove-to-glove and glove-to-bench unnecessarily. Treat gloves as a controlled surface.
SOP disclaimer (customer-facing): The guidance above is provided as a suggested SOP template and training aid. Each facility must review, adapt, validate, and approve procedures based on its specific process, risk assessment, and regulatory expectations. SOSCleanroom provides best-in-class cleanroom consumables and educational guidance; your Quality/Engineering/Operations teams own final SOP content and implementation.
9) Standards and CCS alignment notes (U.S.-first, with EU Annex 1 context)
Glove selection and glove-change discipline should tie back to a contamination control strategy (CCS) that is documented, trained, and monitored. In the U.S., teams commonly anchor terminology and classification using ISO 14644 concepts and then align behaviors to FDA expectations for contamination control in aseptic processing where applicable. For sterile operations and compounding contexts, USP <797> / USP <800> may also influence glove strategy (facility- and process-dependent). EU GMP Annex 1 is often used as a global benchmark to strengthen CCS thinking and reduce personnel-driven contamination risk, but it should be treated as guidance context for U.S. programs — not a U.S. legal requirement.
10) Common failure modes
- Silent tears at pinch points: repeated cap twists, sharp edges, and over-gripping can create micro-tears that do not show visually until wet work begins.
- Cuff roll-down and sleeve gaps: incomplete cuff seating and sleeve friction can open contamination pathways at the gown interface.
- Residue transfer from “clean-looking” gloves: glove-to-bench contact and wet cuffs can move residues quickly even when particles look controlled.
- Latex sensitivity events: if latex allergy is a risk, use a nitrile alternative and align signage/training to avoid accidental exposure.
11) Closest competitors
If you need the same ISO class but want a different material or risk posture, these SOSCleanroom options are commonly evaluated alongside CE4-200:
-
Ansell 93-401 Nitrilite Cleanroom Nitrile Gloves (Class 10 / ISO 4): nitrile alternative for programs avoiding latex proteins and accelerator-related concerns.
SOS link: https://www.soscleanroom.com/product/brands/ansell-93-401-nitrilite-cleanroom-nitrile-gloves-class-10-iso-4/
-
Ansell BNAL BioClean Nerva Cleanroom Nitrile Gloves (Class 10 / ISO 4): extended-length nitrile option when the gown-to-glove interface and forearm coverage are the risk drivers.
SOS link: https://www.soscleanroom.com/product/brands/ansell-bnal-bioclean-nerva-cleanroom-nitrile-gloves-class-10-iso-4/
12) Program fit (why SOSCleanroom)
SOSCleanroom supports controlled-environment programs that need dependable, best-in-class consumables with continuity you can trust. We do not compromise on glove quality for critical environments — gloves are a primary contamination-control interface and a critical control point for yield, sterility assurance, and investigation reduction.
13) Source basis
SOSCleanroom product page (primary)
https://www.soscleanroom.com/product/brands/ansell-ce4-200-microflex-cleanroom-latex-gloves-class-10-iso-4/
SOS-hosted Product Data Sheet PDF (preferred stable reference)
https://www.soscleanroom.com/content/Ansell_PDF/microflex-ce4-200_pds_us.pdf
Manufacturer page (Ansell)
https://www.ansell.com/us/en/products/microflex-ce4-200/pds/2hiftRmzSwQDaoVte5HPmQ
Distributor validation (third-party)
https://cleanroomtechnology.com/sos-cleanroom-supply-becomes-ansell-authorised-distributor-209576
Standards/regulatory bodies (reference URLs)
ISO (ISO 14644-1 page reference): https://www.iso.org/standard/53394.html
FDA: https://www.fda.gov
ASTM: https://www.astm.org
IEST: https://www.iest.org
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
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Last reviewed: Jan. 10, 2026
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