Akers bn4000l

by Akers Industries, Inc.

Akers bn4000l is a Class I device made by Akers Industries, Inc., cleared under FDA 510(k) K133307 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 00759326048134), active as of 23 Oct 2026.

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) K133307↗

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00759326048134 UDI-DI	Date27 Oct 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK133307	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 00759326048134
FDA 510(k) database 510(k) number K133307

Across registries

2 registries list this device

FDA 510(k) K133307 Active
FDA GUDID UDI-DI 00759326048134 listed 27 Oct 2022 Listed

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Withdrawn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: bn4000l

Primary DI / UDI-DI: 00759326048134
510(k) Number: K133307
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

Other devices from Akers Industries, Inc.

Akers W101

Class I
Akers w104

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Akers tn100

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Akers n4000xl

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See all devices from Akers Industries, Inc. →

Properties

Single use
Lot / batch number
Expiration date
Manufacturing date

Other properties (11, all answered No)