Truline A162341

by Arbill Industries, Inc. 2 variants

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) K133307↗

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	Number10850052602120 UDI-DI	Date8 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK133307	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 10850052602120
FDA 510(k) database 510(k) number K133307

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Withdrawn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: Truline
Generic name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / reference: A162341

Primary DI / UDI-DI: 10850052602120
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 Arbill Industries, Inc.

Truline A142343

Class I
Truline A122344

Class I
Truline A112344

Class I
Truline A112353

Class I
Truline A155021

Class I
Truline A112342

Class I

See all devices from Arbill Industries, Inc. →

Properties

Single use

Other properties (14)

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
Lot / batch number: No
Serial number: No
Expiration date: No
Manufacturing date: No