Identity
- Trade Name
- PROMEDIX FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-L,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician FDA UDI
- Model / Reference
- PMD-HG5B-L FDA UDI
- Description
- Heavy Duty Medical Exam Nitrile Disposable Gloves,Heavy Duty 5 Mil-100 Pcs-L,Black,Disposable Powder-Free Latex-Free Glove for Medical, Cooking, Cleaning,Esthetician FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897147760081 FDA UDI
- 510(k) Number
- K123869 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Promedix by Hong Kong Promedix Company Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
- VitalGard® Nitrile — Dash Medical Gloves, Inc. · Class I
- Hongray — Grand Work Plastic Products Co., Ltd. · Class I
- Get-A-Grip — SUMMIT GLOVE INC. · Class I
- MARK3 — CARGUS INTERNATIONAL, INC · Class I
- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
- FINISHMASTER — Bunzl USA Holdings LLC · Class I
- Medicom AssureTouch — AMD Medicom Inc · Class I
Cleared under the same submission
K123869 also covers:
- HANDCOVERS — Balco Industries Inc.
- HANDCOVERS — Balco Industries Inc.
- HANDCOVERS — Balco Industries Inc.
- HANDCOVERS — Balco Industries Inc.
- HANDCOVERS — Balco Industries Inc.
- HANDCOVERS — Balco Industries Inc.
- HANDCOVERS — Balco Industries Inc.
- HANDCOVERS — Balco Industries Inc.
- PROMEDIX — HONG KONG PROMEDIX COMPANY LIMITED
- PROMEDIX — HONG KONG PROMEDIX COMPANY LIMITED
- PROMEDIX — HONG KONG PROMEDIX COMPANY LIMITED
- PROMEDIX — HONG KONG PROMEDIX COMPANY LIMITED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hong Kong Promedix Company Limited
Sources (1)
- FDA UDI 2bd67d20-7cc7-42d1-8576-d73b41ac9dce 34 fields · synced Jun 1, 2026