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510(k) K822433

GARDS (UNSCENTED, MENSTRUAL PAD) by Hospital Specialty Co. — Product Code HHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1982
Date Received
August 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Menstrual, Unscented
Device Class
Class I
Regulation Number
884.5435
Review Panel
OB
Submission Type

An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.

Other clearances by Hospital Specialty Co.

  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K941099 — CLEAN-SORB (September 30, 1994)
  • K882094 — GARDS DEODORANT SANITARY NAPKIN (September 22, 1988)
  • K880454 — AT EASE STRESS PAD (June 16, 1988)
  • K880455 — AT EASE ADULT DIAPER (April 14, 1988)
  • K822242 — SANITARY/OB NAPKINS (September 9, 1982)

Other clearances for product code HHD

  • K071827 — ALWAYS MENSTRUAL PADS (September 20, 2007)
  • K012629 — ALWAYS DUETS (October 5, 2001)
  • K003843 — ENVIVE MINIFORMS (February 8, 2001)
  • K993870 — UNSCENTED INTERLABIAL MENSTRUAL PAD (January 18, 2000)
  • K980395 — GLADRAGS COTTON MENSTRUAL PAD (April 16, 1998)
  • K953470 — FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (November 21, 1995)
  • K953633 — UNSCENTED MENSTRUAL PAD (November 1, 1995)
  • K953667 — UNSCENTED CURVED ULTRATHIN MAXI PADS (November 1, 1995)
  • K953668 — UNSCENTED ULTRATHIN MAXI PAD (November 1, 1995)
  • K953553 — UNSCENTED MENSTRAL PAD (October 27, 1995)