510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LYZClass I

Vinyl Patient Examination Glove

21 CFR 880.6250 / General Hospital
FDA source (opens on fda.gov)

LYZ is the FDA product code for Vinyl Patient Examination Glove, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants". As of , FDA records hold 799 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LYZ
Device name
Vinyl Patient Examination Glove
FDA definition
A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
799
Ingested recalls
7

Clearances, product code LYZ

By decision year
799 clearances under product code LYZ with a decision year between 1989 and 2026, 2010 the highest year at 72.
Show the numbers
510(k) clearances under FDA product code LYZ by decision year
YearClearances
198970
199012
19919
19922
19933
199410
19959
199610
199718
199821
199936
200038
200122
200220
200350
200431
200532
200627
200736
200818
200949
201072
201133
201225
20138
201440
201514
201611
20179
201810
20194
20204
202130
202210
20232
20241
20252
20261

Applicants with the most clearances

Product code LYZ
Applicants holding the most 510(k) clearances under product code LYZ
ApplicantClearances
Shanghai Antares Industries, Inc.14
BD Becton Dickinson Vacutainer Systems Preanalytic13
Ever Light Plastic Products Co., Ltd.11
Grand Work Plastic Products Co., Ltd.11
Shanghai Palomar Mountain Industries, Inc.10
Shijiazhuang Hongxiang Plastics Products Co., Ltd.9
Arista Latindo Industrial, Ltd. P.T.8
Canopus Medical Supply Co., Ltd.8
Shijiazhuang Great Vision Plastic Products Co., LT8
Rich Mountain Medical Products, Inc.7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 128 companies shown, in name order