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NIOSH Respiratory Protective Device Information
Updated August 18, 2021
NIOSH CA 2021-1038
August 2021
The National Institute for Occupational Safety and Health (NIOSH) has revoked ALL approvals issued to Shanghai Dasheng Health Products Manufacture Co., Ltd. The revoked approval numbers are provided below. The revocation includes all private label versions.
As of August 13 , 2021, any Shanghai Dasheng Health Products Manufacture Co., Ltd. respirator marked with a NIOSH approval label indicating any of the approval numbers below is no longer NIOSH-approved:
TC-84A-4329, TC-84A-4330, TC-84A-4331, TC-84A-4332, TC-84A-4334, TC-84A-4335, TC-84A-4336, TC-84A-4337, TC-84A-4398, TC-84A-4399, TC-84A-4400, TC-84A-4401, TC-84A-4463, TC-84A-4464, TC-84A-4465, TC-84A-4466, TC-84A-4467, TC-84A-4468, TC-84A-4469, TC-84A-4470, TC-84A-4471, TC-84A-4472, TC-84A-4473, TC-84A-4483, TC-84A-4484, TC-84A-4485, TC-84A-4486, TC-84A-4487, TC-84A-8150, TC-84A-8425, TC-84A-8543, TC-84A-8544, TC-84A-8545, TC-84A-8546, TC-84A-8547, TC-84A-8634, TC-84A-8635, and TC-84A-8636
Revocation also means that respirators bearing any of the NIOSH approval numbers listed above may no longer be manufactured, assembled, sold, or distributed. As of August 13, 2021, respirators bearing the NIOSH aproval numbers listed above are no longer considered approved and may not be used in fullfillment of any standard or statute requiring the use of a NIOSH approved respirator.
Shanghai Dasheng Health Products Manufacture Co., Ltd. failed to control the design, labeling, and quality management as required by 42 C.F.R. Part 84. Thus, NIOSH has revoked these approvals in accordance with the authority granted 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.”