What is FDA product code LZA?

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.

General Hospital › MiscellaneousPolymer Patient Examination Glove

Examination Gloves – Type C (Nitrile Gloves)

Name: Examination gloves – Type C (Nitrile gloves)
Brand: Examination gloves – Type C (Nitrile gloves)

Type C examination gloves are disposable nitrile gloves worn on the examiner’s hands or fingers during medical examinations. They provide a barrier intended to prevent contamination between…

Registry build 21.09.26

Type C examination gloves are disposable nitrile gloves worn on the examiner’s hands or fingers during medical examinations. They provide a barrier intended to prevent contamination between patient and examiner.

The gloves are blue, single-layer, powder-free and nonsterile. They are intended for adults and supplied for over-the-counter use in small, medium, large and extra-large sizes.

Listed Item

Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 1000PCS

Size and Thickness

Width and minimum length differ across the four sizes. The specified minimum material thickness stays the same: 0.080 mm at the palm and 0.150 mm at the fingers. These values describe the glove construction across the range.

83manufacturers in China registered for this device type

4catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shandong (27), Guangdong (10), Jiangsu (8). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LZA
Manufacturer	City	Province	Registered as	Device types
YUE Kang Anhui Medical Products Co., Ltd.	Huaibei	Anhui	Contract manufacturer	5
Opus Gloves Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	5
Better Care Plastic Technology Co., Ltd.	Shenze County	Hebei	Contract manufacturer	4
Xingyu Medical Tech Co., Ltd.	Weifang	Shandong	Contract manufacturer	4
Lingshi Hongruida Health Protection Technology Co., Ltd.	Jinzhong	Shanxi	Contract manufacturer	4
Zhangjiagang Blackbox Plastic Products Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	4
Zhangjiagang Dayu Rubber Products Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	4
Xuzhou Full Sun Medical Products Ltd.	Pizhou	Jiangsu	Contract manufacturer	3
Zhongnuo Medical Products Co., Ltd.	Tangshan	Hebei	Contract manufacturer	3
Anhui Kindguard Medical Supplies Technology Co., Ltd.	Suzhou	Anhui	Contract manufacturer	2
Puyang Linshi Medical Supplies Co., Ltd.	Puyang	Henan	Contract manufacturer	2
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146

Showing 12 of 83. All 83 manufacturers in China registered for Polymer Patient Examination Glove

Record

Regulatory record for Examination gloves → Type C (Nitrile gloves)
Listed by	Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., China
FDA product code	LZA
Device type	Polymer Patient Examination Glove
Device class	Class 1
Regulation	21 CFR 880.6250
510(k)	K212290
Record published	2022-07-25

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for Examination gloves → Type C (Nitrile gloves)
Catalogue number	Per pack	Status
L	100	In distribution
S	100	In distribution
XL	100	In distribution
M	100	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline	Medline Industries, Inc.	255
Microflex	Ansell Healthcare Product	185
FifthPulse	Jeg & Sons Inc.	135
SW	SW Safety Solutions Inc.	130
Halyard	O&M Halyard, Inc.	120
Basic	Intco Medical Industries, Inc.	119
Cranberry	Ascend Eagle, Inc.	109
1st Choice	Ammex Corporation	101
JMU	JMU Dental, Inc	90
Vivit Supply	Vivit Supply LLC	86
McKesson	Mckesson Medical-Surgical Inc.	75
Natural Extensions	Benco Dental Supply Co.	74

Showing 12 of 930. All products under Polymer Patient Examination Glove

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K212290	2021-10-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.