The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Motex Polyisoprene Powder-free Surgical Gloves Model # 6412(6432) And # 6512(6532).
| Device ID | K123126 |
| 510k Number | K123126 |
| Device Name: | MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) |
| Classification | Surgeon's Gloves |
| Applicant | SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 369, JIASONG ZHONG ROAD HUAXIN, QINGPU Shanghai, CN 201708 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 369, JIASONG ZHONG ROAD HUAXIN, QINGPU Shanghai, CN 201708 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-04 |
| Decision Date | 2014-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16930518062768 | K123126 | 000 |
| 16930518002948 | K123126 | 000 |
| 16930518002955 | K123126 | 000 |
| 16930518002962 | K123126 | 000 |
| 16930518002979 | K123126 | 000 |
| 16930518002986 | K123126 | 000 |
| 16930518002993 | K123126 | 000 |
| 16930518003013 | K123126 | 000 |
| 16930518062720 | K123126 | 000 |
| 16930518062737 | K123126 | 000 |
| 16930518062744 | K123126 | 000 |
| 16930518062751 | K123126 | 000 |
| 16930518002931 | K123126 | 000 |