The following data is part of a premarket notification filed by Sanrea Healthcare Products Pvt Ltd with the FDA for Sancare Sterile Latex Examination Gloves (also Marketed As Glovtek Sterile Latex Examination Gloves).
| Device ID | K171367 |
| 510k Number | K171367 |
| Device Name: | SANCARE STERILE LATEX EXAMINATION GLOVES (also Marketed As GLOVTEK STERILE LATEX EXAMINATION GLOVES) |
| Classification | Latex Patient Examination Glove |
| Applicant | Sanrea Healthcare Products Pvt Ltd Plot#P-56, Pearl Road, Kinfra IIT Park, Kanjikode Palakkad, IN 678 621 |
| Contact | Jose Paul M |
| Correspondent | Jose Paul M Sanrea Healthcare Products Pvt Ltd Plot#P-56, Pearl Road, Kinfra IIT Park, Kanjikode Palakkad, IN 678 621 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2018-01-26 |
| Summary: | summary |