Medicom AssureTouch 9985-E
Medicom AssureTouch 9985-E is a Class I device made by AMD Medicom Inc, cleared under FDA 510(k) K240629 on 28 May 2024 (1 earlier submission) and listed in FDA GUDID since 27 Jul 2023 (UDI-DI 10686864060151), active as of 2 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240629 | Date28 May 2024 | StatusActive |
| United States | GUDID listing | Number10686864060151 | Date27 Jul 2023 | StatusListed |
Official records
- AccessGUDID record 10686864060151
- FDA 510(k) database K240629
- FDA 510(k) database K171873
Across registries
- FDA 510(k) K240629 decided 28 May 2024 Active
- FDA GUDID UDI-DI 10686864060151 listed 27 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K171873
- Listed FDA GUDID 10686864060151
- Cleared FDA 510(k) K240629
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medicom AssureTouch
- Generic name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Model / Ref / Catalog
- 9985-E
- Primary DI / UDI-DI
- 10686864060151
- FDA product code
- LZC, LZA
- GMDN term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Device class
- Class I
- Regulation number
- 880.6250
- GUDID distribution status
- In Commercial Distribution