Identity
- Trade Name
- SafeTouch Sterile Latex Surgical Gloves, 8 1/2 FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Sterile-EO, Powder-Free / Cuffed FDA UDI
- Model / Reference
- 2385 FDA UDI
- Description
- Sterile-EO, Powder-Free / Cuffed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784238517 FDA UDI
- 510(k) Number
- K000896 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial
SafeTouch Sterile Latex Surgical Gloves, 8 1/2 by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hevea-latex surgical glove, non-powdered, non-antimicrobial.
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- MocareHealth — Motex Healthcare(Anhui)Co., Ltd. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- HALYARD — Ansell Healthcare Product · Class I
- MocareHealth — Motex Healthcare(Anhui)Co., Ltd. · Class I
- HALYARD — Ansell Healthcare Product · Class I
Cleared under the same submission
K000896 also covers:
- SafeTouch Sterile Latex Surgical Gloves, 6 1/2 — Dynarex Corp.
- SafeTouch Sterile Latex Surgical Gloves, 6.0 — Dynarex Corp.
- SafeTouch Sterile Latex Surgical Gloves, 7 1/2 — Dynarex Corp.
- SafeTouch Sterile Latex Surgical Gloves, 7.0 — Dynarex Corp.
- SafeTouch Sterile Latex Surgical Gloves, 8.0 — Dynarex Corp.
- SafeTouch Sterile Latex Surgical Gloves, 9.0 — Dynarex Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 70d3996e-a4da-471a-a008-c28ed88a7441 34 fields · synced May 31, 2026