The following data is part of a premarket notification filed by Advanced Health Products, Lot 60 & 61 with the FDA for Powder Free Blude Nitrile Patient Examination Glove, Non-sterile.
| Device ID | K132354 |
| 510k Number | K132354 |
| Device Name: | POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | ADVANCED HEALTH PRODUCTS, LOT 60 & 61 LORONG SENAWAND 3/2 SENAWANG INDUSTRIAL ESTATE Seremban, Negeri Sembilan Darul, MY 70450 |
| Contact | Francis V |
| Correspondent | Francis V ADVANCED HEALTH PRODUCTS, LOT 60 & 61 LORONG SENAWAND 3/2 SENAWANG INDUSTRIAL ESTATE Seremban, Negeri Sembilan Darul, MY 70450 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-29 |
| Decision Date | 2014-06-30 |
| Summary: | summary |