Akers n4000l

by Akers Industries, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

510(k) K110981↗

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00759326049131 UDI-DI	Date27 Oct 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK110981	Date—	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Akers
Generic name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / reference: n4000l

Primary DI / UDI-DI: 00759326049131
510(k) Number: K110981
FDA product code: 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

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Properties

Single use
Lot / batch number
Expiration date
Manufacturing date

Other properties (11)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Contains latex: No
Prescription use: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No