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Amerisource Bergen 10908

by Bp Pharmaceuticals Laboratories Unlimited Company

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K102444

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00368001109086 UDI-DI Date4 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102444 Date22 Nov 2010DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Amerisource Bergen
Generic name
Vinyl examination/treatment glove, non-powdered
Model / reference
10908
Primary DI / UDI-DI
00368001109086
510(k) Number
FDA product code
LYZ
GMDN term
Vinyl examination/treatment glove, non-powdered
Device class
Class I
Regulation number
880.6250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vinyl examination/treatment glove, non-powdered

Cleared under the same submission (K102444)

Show all (12)

Other devices from Bp Pharmaceuticals Laboratories Unlimited Company

See all devices from Bp Pharmaceuticals Laboratories Unlimited Company →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No