Basic NGPF1035

by Intco Medical 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

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	NumberB845NGPF10351 UDI-DI	Date27 Oct 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK121992	Date16 Oct 2012Decided	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Withdrawn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: Basic
Generic name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Ref / Catalog: NGPF1035
Description: BASIC Synguard Nitrile Exam Gloves

Primary DI / UDI-DI: B845NGPF10351
510(k) Number: K121992
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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See all devices from Intco Medical Industries, Inc. →

Properties

Single use
Over-the-counter

Other properties (13)

Supplied sterile: No
Sterilise before use: No
Implantable: No
Contains latex: No
Prescription use: 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