Surgical Gloves — Powder-Free (Sterile)
Sterile, powder-free surgical gloves engineered for precision, comfort, and safety in the operating room. Micro-textured finish enhances instrument control; anatomical fit and beaded cuffs support long procedures with reduced hand fatigue. Available in full size range for an exacting fit. OEM/private-label configurations supported by Proviha.
Meets Standards
- ASTM D3577 (Surgical Rubber Gloves)
- EN 455 Parts 1–4 (Medical Gloves)
- ISO 11137 / EO Sterilization validation*
*Sterilization method subject to brand/OEM configuration (Gamma or EO).
Quality & Safety
- AQL 1.5 pinhole testing (typical for sterile surgical)
- Biocompatibility to ISO 10993 (cytotoxicity, sensitization, irritation)
- Latex protein management & powder-free surface
- Finish
- Micro-textured, chlorinated/polymer-coated
- Fit
- Anatomical (left/right), beaded cuff
- Sterility
- Sterile (Gamma or EO)
Technical Specifications
| Material | Natural Rubber Latex (powder-free). Nitrile variant available on request. |
|---|---|
| Color | Natural (off-white) or per OEM brand color. |
| Surface / Grip | Micro-textured; polymer or chlorinated coating for donning. |
| Length | Approx. 285 ± 10 mm (size dependent). |
| Thickness | Meets ASTM D3577 minimums (finger > palm; exact values per OEM spec). |
| Sizes | 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 (marked L/R). |
| Sterilization | Ethylene Oxide (EO) or Gamma; sterility assurance level validated. |
| Biocompatibility | ISO 10993 (cytotoxicity, sensitization, irritation) compliant materials. |
Packaging & Labeling
- 1 pair per peel pouch (L/R), 50 pouches per dispenser box (100 pcs).
- 10 dispenser boxes per master carton (1,000 pcs) — configurable per OEM.
- Lot, size, and sterility indicators on each pouch; barcodes per market requirement.
Regulatory & Compliance
- Meets ASTM D3577 and EN 455 requirements.
- ISO 13485 quality-managed manufacturing (per partnered site).
- Markets: CE-marked / other registrations subject to brand/OEM configuration.
Typical Applications
- Surgical procedures requiring sterile barrier protection.
- Operating theatre, minor OT, and sterile intervention suites.
- Tasks needing enhanced grip and tactile sensitivity.
Storage & Shelf Life
- Store in a cool, dry place (≤ 30 °C), away from direct sunlight and ozone.
- Keep in original packaging until use; follow pouch sterility indicators.
- Typical shelf life up to 5 years from DOM, subject to storage conditions.
OEM / Private-Label Options
Proviha supports OEM/private-label for sterile surgical gloves, including custom artwork, multi-language IFUs, barcode standards, and carton optimization for target markets. We coordinate end-to-end, including packaging procurement, sterilization cycles, and shipment packing lists aligned to your regulatory pathway.