SurgiMac

Blue Nitrile 300/BX, 10/CS. Extra Large. MacSoft. Thailand.

Registry build 21.09.26
32manufacturers in China registered for this device type
135catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (12), Hebei (5), Guangdong (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OPJ
Manufacturer City Province Registered as Device types
Grand Work Plastic Products Co., Ltd. Zanhuang Hebei Contract manufacturer 5
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
Ever Light Plastic Products Co., Ltd. Shijiazhuang Hebei Contract manufacturer 2
Ever Shine Plastic Technology Co., Ltd. Shijiazhuang Hebei Contract manufacturer 2
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Allmed Medical Products Co., Ltd. Zhijiang Hubei Contract manufacturer 43
Allmed Industrial Limited Shenzhen Guangdong Manufacturer 42
Xiamen Firstcare IMP. & EXP. Co., Ltd. Xiamen Fujian Exporter 40

Showing 12 of 32. All 32 manufacturers in China registered for Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs

Record

Regulatory record for SurgiMac
Listed by Surgimac LLC
FDA product code OPJ
Device type Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs
Device class Class 1
Regulation 21 CFR 880.6250
Record published 2024-12-16
Record revised 2024-05-13 (version 2)

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
T5116-L 200 In distribution
9119-XS 100 In distribution
2118L 100 In distribution
5116M 200 In distribution
2218L 200 In distribution
T2118L-Case 1,000 In distribution
2115-20-L-Case 2,000 In distribution
T2218-L-CS 2,000 In distribution
DXL4119 100 In distribution
4119-XL-CS 1,000 In distribution
T6116-M-CS 3,000 In distribution
T2115XS-Case 1,000 In distribution
2119XL 100 In distribution
T2316-S-CS 3,000 In distribution
T5116-L-CS 2,000 In distribution
T6116-XS 300 In distribution
6116S 100 In distribution
2116S 100 In distribution
2119XL-Case 1,000 In distribution
9119-XL-CS 1,000 In distribution
4116XL 100 In distribution
2316S-Case 3,000 In distribution
5116XL 200 In distribution
6116-XL-Case 3,000 In distribution
T2216-S-CS 2,000 In distribution
T5116-XS-CS 2,000 In distribution
T2219-XL-CS 2,000 In distribution
6116-XL 300 In distribution
6116-M-Case 3,000 In distribution
4116L 100 In distribution
5116SCASE 2,000 In distribution
6116-L 300 In distribution
13-1178 In distribution
T2215-XS 200 In distribution
T2318-L-CS 3,000 In distribution
2117M 100 In distribution
T2117M-Case 1,000 In distribution
2315XS 300 In distribution
2118L-Case 1,000 In distribution
T2116S 100 In distribution
2216S-Case 2,000 In distribution
2318L-Case 3,000 In distribution
6116M 100 In distribution
4118-L-CS 1,000 In distribution
6116SMCASE 1,000 In distribution
5116S 200 In distribution
4116M 100 In distribution
T2115XS 100 In distribution
4119-XL-CS 1,000 In distribution
5116LCASE 2,000 In distribution
9119-XS-CS 1,000 In distribution
T6116-M 300 In distribution
T5116-XL 200 In distribution
T2315-XS-CS 3,000 In distribution
T2118L 100 In distribution
5116XLCASE 2,000 In distribution
2115XS-Case 1,000 In distribution
2219XL-Case 2,000 In distribution
9119-M 100 In distribution
4116SCASE 1,000 In distribution
2117M-Case 1,000 In distribution
6116-S 300 In distribution
2116XSCASE 2,000 In distribution
T2316-S 300 In distribution
4116LCASE 1,000 In distribution
T2218-L 200 In distribution
T2319-XL 300 In distribution
T6116-XS-CS 3,000 In distribution
T2217-M-CS 2,000 In distribution
2115XS 100 In distribution
6116-XS 300 In distribution
9119-L-CS 1,000 In distribution
T5116-XS 200 In distribution
T2216-S 200 In distribution
2219XL 200 In distribution
4118-L-CS 1,000 In distribution
4118L 100 In distribution
T5116-M 200 In distribution
2317M 300 In distribution
2319XL-Case 3,000 In distribution
2115-20-M-Case 2,000 In distribution
5116L 200 In distribution
T2317-M 300 In distribution
T2219-XL 200 In distribution
4116XLCASE 1,000 In distribution
T2215-XS-CS 2,000 In distribution
4116XS 100 In distribution
2116S-Case 1,000 In distribution
9119-S-CS 1,000 In distribution
5116MCASE 2,000 In distribution
6116-L-Case 3,000 In distribution
T5116-M-CS 2,000 In distribution
T6116-L 300 In distribution
2115-20-S-Case 2,000 In distribution
6116-XS-Case 3,000 In distribution
T6116-L-CS 3,000 In distribution
6116-M 300 In distribution
T2119XL-Case 1,000 In distribution
9119-L 100 In distribution
2115-20-XS-Case 2,000 In distribution
9119-S 100 In distribution
T5116-S-CS 2,000 In distribution
2217M-Case 2,000 In distribution
2319XL 300 In distribution
4118L 100 In distribution
T2319-XL-CS 3,000 In distribution
2215XS-Case 2,000 In distribution
6116SCASE 1,000 In distribution
T6116-S 300 In distribution
9119-M-CS 1,000 In distribution
T6116-XL 300 In distribution
T2315-XS 300 In distribution
4119XL 100 In distribution
T5116-S 200 In distribution
2216S 200 In distribution
2315XS-Case 3,000 In distribution
4116S 100 In distribution
2316S 300 In distribution
9119-XL 100 In distribution
T2217-M 200 In distribution
T6116-XL-CS 3,000 In distribution
T6116-S-CS 3,000 In distribution
2115-20-XL-Case 2,000 In distribution
T2317-M-CS 3,000 In distribution
6116-S-Case 3,000 In distribution
2215XS 200 In distribution
T2119XL 100 In distribution
2217M 200 In distribution
2318L 300 In distribution
2317M-Case 3,000 In distribution
2218L-Case 2,000 In distribution
T2318-L 300 In distribution
T5116-XL-CS 2,000 In distribution
T2117M 100 In distribution
4116MCASE 1,000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tronex International, Inc. Tronex International, Inc. 14
Blueline Transparent Supply Solutions Ltd. 10
SemperShield EC Nitrile Exam Glove Harps USA, Inc. 9
Ultraguard True Products International, LLC 9
OmniTrustTM Omni Intl., Inc. 9
Domrex™ PI Gloves Domrex Pharma Inc 8
Halyard O&M Halyard, Inc. 7
Pharma-Glove CR McGowan Enterprises, Inc. 7
Tender Touch 100 Nitrile Exam Glove Harps USA, Inc. 6
SemperSure Green Nitrile Exam Glove Harps USA, Inc. 6
StarMed Select Nitrile Exam Glove Harps USA, Inc. 6
force+ Harps USA, Inc. 6

Showing 12 of 47. All products under Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs

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