PrimaPro

PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove, X-Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single…

Registry build 21.09.26

PrimaPro Gentle Guard Comfort Fit Ultra Shield Nitrile Powder Free Examination Glove, X-Small, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

83manufacturers in China registered for this device type
45catalogue numbers in this listing

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 PrimaPro
Listed by Primary Products Company
FDA product code LZA
Device type Polymer Patient Examination Glove
Device class Class 1
Regulation 21 CFR 880.6250
510(k) K171422
Record published 2020-09-09
Record revised 2024-07-02 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Contains natural rubber latex
Label carries lot or batch number
Packaging Case of 10

Catalogue Numbers

Catalogue numbers for PrimaPro
Catalogue number Size Per pack Status
225-45 180 In distribution
215-45 100 In distribution
244-45 100 In distribution
223-45 200 In distribution
521-45 200 In distribution
214-45 100 In distribution
243-45 100 In distribution
211-45 100 In distribution
252-45 100 In distribution
525-45 180 In distribution
253-45 100 In distribution
273-45 200 In distribution
210-45 100 In distribution
255-45 90 In distribution
213-45 100 In distribution
212-45 100 In distribution
523-45 200 In distribution
271-45 200 In distribution
421-45 100 In distribution
524-45 200 In distribution
221-45 200 In distribution
230-45 100 In distribution
242-45 100 In distribution
520-45 200 In distribution
424-45 100 In distribution
251-45 100 In distribution
522-45 200 In distribution
270-45 200 In distribution
274-45 200 In distribution
232-45 100 In distribution
231-45 100 In distribution
235-45 90 In distribution
224-45 200 In distribution
222-45 200 In distribution
233-45 100 In distribution
610-45 100 In distribution
216-45 90 In distribution
254-45 100 In distribution
275-45 200 In distribution
241-45 100 In distribution
422-45 100 In distribution
234-45 100 In distribution
220-45 200 In distribution
423-45 100 In distribution
272-45 200 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer