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Examination gloves – Type A (Latex gloves)
FDA UDIClass I (US FDA UDI)
by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Identity
- Trade Name
- Examination gloves – Type A (Latex gloves) FDA UDI
- Generic Name
- Hevea-latex 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: 2000PCS 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: 2000PCS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972267280352 FDA UDI
- 510(k) Number
- K214017 FDA UDI
- FDA Product Code
- LYY FDA UDI
- GMDN Term
- Hevea-latex 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
Yes
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: Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Examination gloves – Type A (Latex gloves) by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K214017 also covers:
- Examination gloves – Type A (Latex gloves) — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Examination gloves – Type A (Latex gloves) — Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
- Examination gloves – Type A (Latex 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 1ca237b8-3394-4363-9f2a-2786013b4f70 34 fields · synced May 30, 2026