Home › MEDTECS (TAIWAN) CORP. › ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask
MEDTECS (TAIWAN) CORP. · Model FM-140G · UDI-DI 04710415360045
10
510(k) clearances
542
Adverse events
12
Recalls
318
Facilities
Description
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-140G are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. The face masks are single use, disposable device, provided non-sterile.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-08 | O&M HALYARD, INC. | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, |
| 2024-11-08 | O&M HALYARD, INC. | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-01-03 | Owens & Minor Distribution, Inc. | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops |
| 2019-10-11 | AMD Medicom Inc. | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a |
| 2019-10-11 | AMD Medicom Inc. | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a |
| 2013-05-15 | Maytex Corp | Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box |
| 2003-06-03 | Safco Dental Supply Co. Inc. | The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.