Cover, Barrier, Protective

Device Code: 2829

Product Code(s): MMP

Device Classification Information

• Device Type ID: 2829
• Device Name: Cover, Barrier, Protective
• Regulation Description: Surgical Drape And Drape Accessories.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 878.4370 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MMP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 6-296 AAMI ANSI PB70:2012
  Liquid Barrier Performance And Classification Of Protective Apparel And Drapes Intended For Use In Health Care Facilities
• 6-363 ISO 11810 Second Edition 2015-12-15
  Lasers And Laser-related Equipment - Test Method And Classification For The Laser-resistance Of Surgical Drapes And/or Patient-protective Covers - Primary Ignition, Penetration, Flame Spread And Secondary Ignition

Total Product Life Cycle

• Device Type ID: 2829
• Device: Cover, Barrier, Protective
• Product Code: MMP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Surgical Drape And Drape Accessories.
• CFR Regulation Number: 878.4370 [🔎]

Device Problems
Break	1
Contamination During Use	1
Expiration Date Error	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien LLC	II	Mar-04-2017
2	NOVADAQ TECHNOLOGIES INC.	II	Sep-28-2017
3	Penner Mfg Inc	II	Mar-20-2015
4	Sybron Dental Specialties	II	Mar-18-2015

TPLC Last Update: 2019-04-02 20:19:24