The following data is part of a premarket notification filed by 5r Med Instruments (chengdu) Co., Ltd. with the FDA for Nitrile Examination Gloves.
Device ID | K210776 |
510k Number | K210776 |
Device Name: | Nitrile Examination Gloves |
Classification | Polymer Patient Examination Glove |
Applicant | 5R MED Instruments (Chengdu) Co., Ltd. Building 9, Section 1, No.618 Of West Kelin Road Chengdu, CN 611130 |
Contact | Yuzhang Pan |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-15 |
Decision Date | 2021-07-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06973675392920 | K210776 | 000 |
06973675391695 | K210776 | 000 |
06973675391008 | K210776 | 000 |
06973675390230 | K210776 | 000 |
06973675390063 | K210776 | 000 |
06973675390001 | K210776 | 000 |