510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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First Quality Hygienic, Inc.

Allendale, NJ, US

First Quality Hygienic, Inc. appears in FDA device records in Allendale, NJ. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for First Quality Hygienic, Inc. between 1993 and 2016. The busiest year on record is 2005, with 3. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for First Quality Hygienic, Inc., by decision year
YearClearances
19931
19962
20021
20032
20053
20151
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super PlHEBSubstantially Equivalent
K151470Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super AbsorbencyHEBSubstantially Equivalent
K051446FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONSHILSubstantially Equivalent
K050660FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONSHEBSubstantially Equivalent
K050067FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSHILSubstantially Equivalent
K032173FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSHILSubstantially Equivalent
K031067FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONSHEBSubstantially Equivalent
K023479FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGESHEBSubstantially Equivalent
K963034FEMTEX GENTLE TOUCH TAMPONSHEBSubstantially Equivalent
K963032FREE CHOICEHEBSubstantially Equivalent
K920238PRIVATE LABELS AND FEMTEXHEBSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2466-2010Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator TamponsLife Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons.Terminated

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