The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Gloves (orange).
| Device ID | K171541 |
| 510k Number | K171541 |
| Device Name: | Powder Free Nitrile Examination Gloves (Orange) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Contact | Chan Yew Men |
| Correspondent | Chan Yew Men Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-26 |
| Decision Date | 2017-09-20 |
| Summary: | summary |