(72 days)
A Sterile surgeon's Glove is worn on the hand of a Surgeon or similar health care person, to prevent contamination between health care providers and the patient during invasive surgical or similar procedures.
Sterile Orthopediig,Surgeon's Glove WITH PROTENT UNEUNG CLAIM (50 MICROGRAMS or LESS)
The provided text is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets those criteria, as typically found in a clinical study report or a detailed pre-market submission.
Therefore, I cannot provide the requested information. The document is strictly a regulatory clearance for a "Regent Biogel Powder-Free Orthopedic Latex Surgical Glove, with Protein Content Labeling Claim (50 Micrograms or Less)," confirming its substantial equivalence to previously marketed devices.
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).