Molnlycke Health Care Us, LLC · Class I · Cleared Mar 13, 2020
| K-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 |
| Applicant | Molnlycke Health Care Us, LLC |
| Product code | KGO |
| Device class | Class I |
| Decision date | Mar 13, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 878.4460 |
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