# K092824: N95 Respirator Mask, Positive Facial Lock with Magic Arch, Model 695

- Pathway: 510(k) (Abbreviated)
- Applicant: Alpha Protech, Inc.
- Decided: Oct 21, 2009 after 37 days
- Product code: MSH (Respirator, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aearo Company's Pleats Plus 1050 Respirator Masks: named in the summary without a submission number

## Indications for use
Alpha Pro Tech's 695 N95 Respirator Mask meets the CDC guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It is intended to be a single use, disposable device. This would also include use as a procedure mask, isolation mask and/or dental face mask.

Source page: https://510kreport.com/device/K092824
Methodology: https://510kreport.com/methodology