FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

POWDER FREE ELASTIC VINYL EXAMINATION GLOVES

Manufacturer

SUN FLOWER GLOVES CO., LTD.

Date Cleared

2002-10-25

(80 days)

Product Code

LYZ

Regulation Number

880.6250

Why did this record match?

Applicant Name (Manufacturer) :

SUN FLOWER GLOVES CO., LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

A vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

POWDER-FREE ELASTIC VINYL EXAMINATION GLOVES

Ask a Question

K Number

Device Name

VINYL EXAMINATION GLOVES POWDER FREE

Manufacturer

SUN FLOWER GLOVES CO., LTD.

Date Cleared

1998-01-30

(39 days)

Product Code

LYZ

Regulation Number

880.6250

Why did this record match?

Applicant Name (Manufacturer) :

SUN FLOWER GLOVES CO., LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Patient examination glove VINYL - POWDER FREE

Ask a Question

Page 1 of 1