The following data is part of a premarket notification filed by Molnlycke Health Care, Us Llc with the FDA for Biogel(r) Pi Ultratouch S Surgical Glove With A Low Dermatitis Potential Claim, Biogel(r) Pi Ultratouch S Indicator Underglove With A Low Dermatitis Potential Claim.
| Device ID | K191869 |
| 510k Number | K191869 |
| Device Name: | Biogel(R) PI UltraTouch S Surgical Glove With A Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove With A Low Dermatitis Potential Claim |
| Classification | Surgeon's Gloves |
| Applicant | Molnlycke Health Care, US LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 |
| Contact | Leonard Stewart |
| Correspondent | Leonard Stewart Molnlycke Health Care, US LLC 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-12 |
| Decision Date | 2020-03-13 |