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510(k) K882094

GARDS DEODORANT SANITARY NAPKIN by Hospital Specialty Co. — Product Code HHL

K882094 is an FDA 510(k) premarket notification submitted by Hospital Specialty Co. for the device "GARDS DEODORANT SANITARY NAPKIN". The FDA issued a decision of Substantially Equivalent on September 22, 1988. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425. Hospital Specialty Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1988
Date Received
May 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Menstrual, Scented, Scented-Deodorized
Device Class
Class II
Regulation Number
884.5425
Review Panel
OB
Submission Type

Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).

Other clearances by Hospital Specialty Co.

  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K941099 — CLEAN-SORB (September 30, 1994)
  • K880454 — AT EASE STRESS PAD (June 16, 1988)
  • K880455 — AT EASE ADULT DIAPER (April 14, 1988)
  • K822242 — SANITARY/OB NAPKINS (September 9, 1982)
  • K822433 — GARDS (UNSCENTED, MENSTRUAL PAD) (August 30, 1982)

Other clearances for product code HHL

  • K962962 — DEODORANT PANTY LINER (October 10, 1996)
  • K962954 — DEODORANT MAXI PAD (October 10, 1996)
  • K962953 — DEODORANT PANTY SHIELD (October 10, 1996)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K913237 — ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD (September 23, 1991)
  • K913238 — ALWAYS, UNSCENTED MENSTRUAL PAD (September 23, 1991)
  • K891473 — TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO (June 7, 1989)
  • K890655 — NEW FREEDOM THIN DEODORANT MAXI PADS (May 1, 1989)
  • K884951 — TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT (January 10, 1989)
  • K884446 — MAXITHINS SUPER PADS, DEODORANT (December 20, 1988)

FDA data resources