510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LZAClass I

Polymer Patient Examination Glove

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

LZA is the FDA product code for Polymer Patient Examination Glove, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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...". As of , FDA records hold 1,176 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LZA
Device name
Polymer Patient Examination Glove
FDA definition
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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
1,180
Ingested recalls
10

Clearances, product code LZA

By decision year
1,180 clearances under product code LZA with a decision year between 1984 and 2026, 2022 the highest year at 146.
Show the numbers
510(k) clearances under FDA product code LZA by decision year
YearClearances
19841
19893
19902
199511
19965
199725
199842
199981
200045
200138
200244
200326
200419
200528
200620
200721
200818
200928
201031
201126
201233
201320
201427
201520
201630
201744
201822
201925
202030
2021139
2022146
202362
202430
202524
202614

Applicants with the most clearances

Product code LZA
Applicants holding the most 510(k) clearances under product code LZA
ApplicantClearances
Shen Wei (USA), Inc.34
Hartalega Sdn Bhd33
Hartalega NGC Sdn Bhd24
Siam Sempermed Corp., Ltd.17
Smart Glove Corp. Sdn Bhd16
Yty Industry (Manjung) Sdn. Bhd.16
Gx Corporation Sdn Bhd15
WRP Asia Pacific Sdn Bhd15
Eco Medi Glove Sdn Bhd14
O&M Halyard, Inc.14

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 369 companies shown, in name order