510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Maytex Corp

Hayward, CA, US

MAYTEX CORP. appears in FDA device records in Hayward, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Maytex Corp between 1989 and 1994. The busiest year on record is 1989, with 2. The most recent is 1994, with 2.

Clearances by year, as a table
510(k) clearance decisions for Maytex Corp, by decision year
YearClearances
19892
19942
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K935315MAYTEX POWDER-FREE LATEX EXAMINATION GLOVESLYYSubstantially Equivalent
K935314MAYTEX LATEX EXAMINATION GLOVES, POWDEREDLYYSubstantially Equivalent
K892183MAYTEX LATEX EXAMINATION GLOVESLYYSubstantially Equivalent
K892082MAYTEX NON-STERILE LATEX EXAM GLOVESLYYSubstantially Equivalent

Registered establishments

FDA registered establishments for Maytex Corp, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29392862939286MAYTEX CORP.23521 FOLEY ST., HAYWARD, CA 94545 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1451-2013Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.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/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain