The following data is part of a premarket notification filed by Shandong Baisheng Medical Products Co., Ltd. with the FDA for Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs.
| Device ID | K161944 |
| 510k Number | K161944 |
| Device Name: | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD. 11 Longshan Rd, Wolong Industy Park Linqu, CN 262600 |
| Contact | Cecily Sheng |
| Correspondent | John Zhao BASIC MEDICAL INDUSTRIES, INC. 805 BARRINGTON AVE Ontario, CA 91764 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-15 |
| Decision Date | 2016-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00097604936149 | K161944 | 000 |
| 00097604936132 | K161944 | 000 |
| 00097604936125 | K161944 | 000 |
| 00097604936118 | K161944 | 000 |
| 00097604936101 | K161944 | 000 |
| 00840064620758 | K161944 | 000 |
| 00840064620741 | K161944 | 000 |
| 00840064620734 | K161944 | 000 |
| 00840064620642 | K161944 | 000 |