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NIOSH Respiratory Protective Device Information

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Subject: Effective Immediately: Revocation of Six Aegle PPE 1 LLC Approvals

NIOSH CA 2024-1089
December 2024

SUMMARY

The National Institute for Occupational Safety and Health (NIOSH) has revoked six approval numbers (provided below) issued to Aegle PPE 1 LLC. Aegle has failed to maintain their quality management system, resulting in a failure to execute their quality control system.

This notice is to announce that any Aegle PPE 1 LLC. respirator with a NIOSH approval label that includes any of the approval numbers below is no longer approved by NIOSH.

Effective Immediately: Voluntary Rescission of two Innonix Technologies Limited Approvals
Approval Number Product Line or Model
84A-9314 C100, Filtering Facepiece
84A-9353 F100, N95 Filtering Facepiece
84A-9368 F110 PLUS, Filtering Facepiece
84A-9390 F100 PLUS, N95 Filtering Facepiece
84A-9391 F200, N95 Filtering Facepiece
84A-9395 C100S, Surgical N95, Filtering Facepiece

Revocation also means that respirators bearing any of the NIOSH approval numbers listed above may no longer be used, manufactured, assembled, sold, or distributed.  As of  December 31, 2024, respirators bearing the NIOSH approval numbers listed above are no longer considered approved and may not be used in fulfillment of any standard or statute requiring the use of a NIOSH Approved® respirator.

Aegle PPE 1 LLC failed to control the  quality management for the approvals  as required by 42 C.F.R. Part 84.  Thus, NIOSH has revoked these approvals in accordance with its authority as set forth in 42 C.F.R. § 84.34, which states, “The Institute reserves the right to revoke, for cause, any certificate of approval issued pursuant to the provisions of this part. Such causes include, but are not limited to, misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the quality control requirements of the certificate of approval.”

Effective Immediately: Revocation of Six Aegle PPE 1 LLC Approvals [PDF – 242 KB]

NIOSH Approved® is a certification mark of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions