The following data is part of a premarket notification filed by Central Medicare Sdn. Bhd. with the FDA for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.
| Device ID | K173942 |
| 510k Number | K173942 |
| Device Name: | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Central Medicare Sdn. Bhd. PT 2609-2620, BT 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Contact | Arivalagan Subramaniam |
| Correspondent | Arivalagan Subramaniam Central Medicare Sdn. Bhd. PT 2609-2620, BT 8, Jalan Changkat Jong Teluk Intan, MY 36000 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811220030343 | K173942 | 000 |
| 30680651476389 | K173942 | 000 |
| 30680651476372 | K173942 | 000 |
| 30680651476365 | K173942 | 000 |
| 30680651476358 | K173942 | 000 |
| 30680651476341 | K173942 | 000 |
| 30680651439360 | K173942 | 000 |
| 30680651439353 | K173942 | 000 |
| 30680651439346 | K173942 | 000 |
| 30680651439339 | K173942 | 000 |
| 30680651439322 | K173942 | 000 |
| 30680651480331 | K173942 | 000 |
| 30680651480348 | K173942 | 000 |
| 30680651480355 | K173942 | 000 |
| 10811220030336 | K173942 | 000 |
| 10811220030329 | K173942 | 000 |
| 10811220030312 | K173942 | 000 |
| 10811220030305 | K173942 | 000 |
| 30680651481321 | K173942 | 000 |
| 30680651481314 | K173942 | 000 |
| 30680651481307 | K173942 | 000 |
| 30680651481291 | K173942 | 000 |
| 30680651481284 | K173942 | 000 |
| 30680651480362 | K173942 | 000 |
| 30680651480379 | K173942 | 000 |