← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K000421

# BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE (K000421)

_Ssl Americas, Inc. (Regent Medical) · KGO · Aug 14, 2000 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K000421

## Device Facts

- **Applicant:** Ssl Americas, Inc. (Regent Medical)
- **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md)
- **Decision Date:** Aug 14, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4460
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K000421](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K000421)

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