Identity
- Trade Name
- PALMCARE FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, antimicrobial FDA UDI
- Device Name
- Palmcare Nitrile Gloves Size Medium FDA UDI
- Model / Reference
- Medium FDA UDI
- Description
- Palmcare Nitrile Gloves Size Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08859751520037 FDA UDI
- 510(k) Number
- K202384 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, 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
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
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, antimicrobial
Palmcare by Hi-Care Thai Gloves Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, antimicrobial.
- Powder Free Nitrile Examination Gloves, Non Sterile Black Colored — Encompass Medical Supplies Inc Limited · Class I
- SAFETY MAX GOLD — Pristine Dental Supplies, Inc. · Class I
- AG GLOVE — ASIA GATE INTERNATIONAL SDN. BHD. · Class I
- Coregloves — SMARTLOGICS LLC · Class I
- Cerulean — J & A Global Inc.
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- AG GLOVE — ASIA GATE INTERNATIONAL SDN. BHD. · Class I
- AG GLOVE — ASIA GATE INTERNATIONAL SDN. BHD. · Class I
Cleared under the same submission
K202384 also covers:
- Wave Blue Nitrile Examination Gloves Powder Free — C&A Marketing, Inc.
- Wave Blue Nitrile Examination Gloves Powder Free — C&A Marketing, Inc.
- Wave Blue Nitrile Examination Gloves Powder Free — C&A Marketing, Inc.
- Wave Blue Nitrile Examination Gloves Powder Free — C&A Marketing, Inc.
- PALMCARE — Hi-Care Thai Gloves Co. , Ltd.
- PALMCARE — Hi-Care Thai Gloves Co. , Ltd.
- PALMCARE — Hi-Care Thai Gloves Co. , Ltd.
- PALMCARE — Hi-Care Thai Gloves Co. , Ltd.
- Velvet Touch — Mrglovz.com LLC
- Velvet Touch — Mrglovz.com LLC
- Velvet Touch — Mrglovz.com LLC
- Velvet Touch — Mrglovz.com LLC
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
- Hi-Care Thai Gloves Co. , Ltd.
Sources (1)
- FDA UDI 28ea6d7a-4e85-40d3-a1fc-0787a632a9c7 35 fields · synced Jun 6, 2026