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Examination gloves – Type C (Nitrile gloves)
FDA UDIClass I (US FDA UDI)
by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Identity
- Trade Name
- Examination gloves – Type C (Nitrile gloves) FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 1000PCS FDA UDI
- Model / Reference
- XL FDA UDI
- Description
- Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 1000PCS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972267280185 FDA UDI
- 510(k) Number
- K212290 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
Yes
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
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Examination gloves – Type C (Nitrile gloves) by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
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
K212290 also covers:
- Examination gloves – Type C (Nitrile gloves) — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Examination gloves – Type C (Nitrile gloves) — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Examination gloves – Type C (Nitrile gloves) — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
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
Sources (1)
- FDA UDI e42a417e-5d7a-4373-8d76-c28e2873a323 34 fields · synced May 30, 2026