The following data is part of a premarket notification filed by Sanrea Healthcare Products Pvt Ltd with the FDA for Sterile Latex Surgical Gloves, Powder Free.
| Device ID | K171550 |
| 510k Number | K171550 |
| Device Name: | Sterile Latex Surgical Gloves, Powder Free |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-26 |
| Decision Date | 2018-07-13 |
| Summary: | summary |