The following data is part of a premarket notification filed by Brightway Holdings Sdn Bhd with the FDA for Brightway Brand Nitrile Examination Gloves, Powder Free, [sterling/grey] Tested For Use With Chemotherapy Drugs.
Device ID | K161215 |
510k Number | K161215 |
Device Name: | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs |
Classification | Polymer Patient Examination Glove |
Applicant | BRIGHTWAY HOLDINGS SDN BHD LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, MY 42100 |
Contact | G. Baskaran |
Correspondent | G. Baskaran BRIGHTWAY HOLDINGS SDN BHD LOT 1559, JALAN ISTIMEWA, BATU BELAH Klang, MY 42100 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-29 |
Decision Date | 2016-12-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10036000507093 | K161215 | 000 |
10036000507086 | K161215 | 000 |
10036000507079 | K161215 | 000 |
10036000507062 | K161215 | 000 |
10036000507055 | K161215 | 000 |