The following data is part of a premarket notification filed by Wear Safe (malaysia) Sdn. Bhd. with the FDA for Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested For Use With Chemotherapy Drugs, With Non-pyrogenic Labeling Claim.
| Device ID | K172420 |
| 510k Number | K172420 |
| Device Name: | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested For Use With Chemotherapy Drugs, With Non-Pyrogenic Labeling Claim |
| Classification | Surgeon's Gloves |
| Applicant | Wear Safe (Malaysia) Sdn. Bhd. LOT 5068 & 5069, BATU 4 1/2, JALAN MERU Klang, MY 41050 |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong Wear Safe (Malaysia) Sdn. Bhd. LOT 5068 & 5069, BATU 4 1/2, JALAN MERU Klang, MY 41050 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2017-09-29 |