Identity
- Trade Name
- Snow Lotus FDA UDI
- Generic Name
- Hevea-latex surgical glove, powdered FDA UDI
- Device Name
- Powdered Sterile Latex Surgical Gloves FDA UDI
- Model / Reference
- 9 FDA UDI
- Description
- Powdered Sterile Latex Surgical Gloves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936610210307 FDA UDI
- 510(k) Number
- K062797 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Hevea-latex surgical glove, 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hevea-latex surgical glove, powdered
Snow Lotus by Beijing Reagent Latex Products Factory — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hevea-latex surgical glove, powdered.
- CUSTOMED — Customed, Inc. · Class I
- CUSTOMED — Customed, Inc. · Class I
- CUSTOMED — Customed, Inc. · Class I
- CUSTOMED — Customed, Inc. · Class I
- CUSTOMED — Customed, Inc. · Class I
- CUSTOMED — Customed, Inc. · Class I
- Snow Lotus — Beijing Reagent Latex Products Factory · Class I
- Snow Lotus — Beijing Reagent Latex Products Factory · Class I
Cleared under the same submission
K062797 also covers:
- Snow Lotus — Beijing Reagent Latex Products Factory
- Snow Lotus — Beijing Reagent Latex Products Factory
- Snow Lotus — Beijing Reagent Latex Products Factory
- Snow Lotus — Beijing Reagent Latex Products Factory
- Snow Lotus — Beijing Reagent Latex Products Factory
- Snow Lotus — Beijing Reagent Latex Products Factory
- Snow Lotus — Beijing Reagent Latex Products Factory
- Snow Lotus — Beijing Reagent Latex Products Factory
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
- Beijing Reagent Latex Products Factory
Sources (1)
- FDA UDI b7d1f28c-eaf9-4d70-a934-a9abe3889c62 34 fields · synced May 31, 2026