Identity
- Trade Name
- Sterile Nitrile Surgical Gloves FDA UDI
- Generic Name
- Nitrile surgical glove, non-powdered FDA UDI
- Device Name
- Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size 7 FDA UDI
- Model / Reference
- 6535 FDA UDI
- Description
- Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size 7 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784653518 FDA UDI
- 510(k) Number
- K122557 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Nitrile surgical glove, non-powdered 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitrile surgical glove, non-powdered
Sterile Nitrile Surgical Gloves by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile surgical glove, non-powdered.
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- FifthPulse — Jeg & Sons Inc. · Class I
- FifthPulse — Jeg & Sons Inc. · Class I
- FifthPulse — Jeg & Sons Inc. · Class I
- CORRECT TOUCH — Ct International · Class I
- Nephron Nitrile — Nephron Nitrile LLC · Class I
- P&P Medical Surgical LLC — P&P Medical Surgical LLC · Class I
Cleared under the same submission
K122557 also covers:
- SUPERFIT — APPLIED DENTAL, INC.
- SUPERFIT — APPLIED DENTAL, INC.
- SUPERFIT — APPLIED DENTAL, INC.
- SUPERFIT — APPLIED DENTAL, INC.
- SUPERFIT — APPLIED DENTAL, INC.
- SUPERFIT — APPLIED DENTAL, INC.
- Sterile Nitrile Surgical Gloves — Dynarex Corp.
- Sterile Nitrile Surgical Gloves — Dynarex Corp.
- Sterile Nitrile Surgical Gloves — Dynarex Corp.
- Sterile Nitrile Surgical Gloves — Dynarex Corp.
- Sterile Nitrile Surgical Gloves — Dynarex Corp.
- Sterile Nitrile Surgical Gloves — 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 88c60558-a3f1-49ee-872e-cf976f8f8961 34 fields · synced May 30, 2026