SurgiMac

Blue Nitrile 100 ct. Extra Large. Case. MaxSoft. Thailand.

Registry build 21.09.26
83manufacturers in China registered for this device type
31catalogue 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 SurgiMac
Listed by Surgimac LLC
FDA product code LZA
Device type Polymer Patient Examination Glove
Device class Class 1
Regulation 21 CFR 880.6250
510(k) K112294
Record published 2023-12-14

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Contains natural rubber latex
Label carries expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for SurgiMac
Catalogue number Size Per pack Status
T4116-S 100 In distribution
T4116-M-Case 1,000 In distribution
2216S 200 In distribution
2217M-Case 2,000 In distribution
T4116-XS 100 In distribution
T4116-XL-Case 1,000 In distribution
2218L-Case 2,000 In distribution
2219XL-Case 2,000 In distribution
2119XL 100 In distribution
2115XS 100 In distribution
2216S-Case 2,000 In distribution
2117M 100 In distribution
2116S 100 In distribution
2219XL 200 In distribution
2118L 100 In distribution
2117M-Case 1,000 In distribution
2218L 200 In distribution
2115XS-Case 1,000 In distribution
T4116-L 100 In distribution
2119XL-Case 1,000 In distribution
2116S-Case 1,000 In distribution
T4116-L-Case 1,000 In distribution
2215XS-Case 2,000 In distribution
T4116-M 100 In distribution
2118L-Case 1,000 In distribution
T4116-XS-Case 1,000 In distribution
2217M 200 In distribution
2215XS 200 In distribution
T4116-S-Case 1,000 In distribution
T4116-XL 100 In distribution
T2116S-Case 1,000 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