PureSense 1068403

by Purelife, LLC

PureSense 1068403 is a Class I device made by Purelife, LLC, cleared under FDA 510(k) K212182 on 11 Dec 2021 and listed in FDA GUDID since 1 Dec 2022 (UDI-DI D79010684031), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD79010684031 UDI-DI	Date1 Dec 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK212182	Date11 Dec 2021Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K212182

Across registries

2 registries list this device

FDA 510(k) K212182 decided 11 Dec 2021 Active
FDA GUDID UDI-DI D79010684031 listed 1 Dec 2022 Listed

Timeline

2 dated events

11 Dec 2021 Cleared FDA 510(k) K212182
1 Dec 2022 Listed FDA GUDID D79010684031

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: PureSense
Generic name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Ref / Catalog: 1068403

Primary DI / UDI-DI: D79010684031
510(k) Number: K212182
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
Manufacturing date

Other properties (12, all answered No)