AmbiNitrile 570-BL-7

by Summit Glove Inc. 2 variants

AmbiNitrile 570-BL-7 is a Class I device made by Summit Glove Inc., cleared under FDA 510(k) K990878 on 21 May 1999 and listed in FDA GUDID since 1 Aug 2020 (UDI-DI 00850018374101), 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

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	Number00850018374101 UDI-DI	Date1 Aug 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK990878	Date21 May 1999Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00850018374101
FDA 510(k) database 510(k) number K990878

Across registries

2 registries list this device

FDA 510(k) K990878 decided 21 May 1999 Active
FDA GUDID UDI-DI 00850018374101 listed 1 Aug 2020 Listed

Timeline

2 dated events

21 May 1999 Cleared FDA 510(k) K990878
1 Aug 2020 Listed FDA GUDID 00850018374101

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: AmbiNitrile
Generic name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / reference: 570-BL-7

Primary DI / UDI-DI: 00850018374101
510(k) Number: K990878
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 Summit Glove Inc.

See all devices from Summit Glove Inc. →

Properties

Single use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)