The following data is part of a premarket notification filed by Careglove Global Sdn Bhd with the FDA for Latex Examination Glove Powder Free.
| Device ID | K161833 |
| 510k Number | K161833 |
| Device Name: | LATEX EXAMINATION GLOVE POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | CAREGLOVE GLOBAL SDN BHD LOT 17479, LRG SENAWANG 3/2, OFF JLN SENAWANG 3 SENAWANG IN Seremban, MY 70450 |
| Contact | Lim Kwee Shyan |
| Correspondent | Lim Kwee Shyan CAREGLOVE GLOBAL SDN BHD LOT 17479, LRG SENAWANG 3/2, OFF JLN SENAWANG 3 SENAWANG IN Seremban, MY 70450 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2017-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09551006060211 | K161833 | 000 |
| 09551006060204 | K161833 | 000 |
| 09551006060198 | K161833 | 000 |
| 09551006060181 | K161833 | 000 |
| 09551006060174 | K161833 | 000 |