Ercon Yek-Nt-001

by Fujian Ercon Medical Management Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

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	Number16973847530003 UDI-DI	Date7 Jul 2021Listed	StatusListed GUDID: in commercial distribution

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Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name: Ercon
Generic Name: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Model / Reference: YEK-NT-001

Primary DI / UDI-DI: 16973847530003
510(k) Number: K210276
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

MRI Safety: MR Unsafe

Other devices from Fujian Ercon Medical Management Co., Ltd.

Disposable Nitrile Gloves

Class I

Properties

Single Use
Over-the-Counter
Lot / Batch Number
Serial Number
Expiration Date
Manufacturing Date

Other properties (8)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No