Drape, Patient, Ophthalmic

Device Code: 2820

Product Code(s): HMT

Device Classification Information

• Device Type ID: 2820
• Device Name: Drape, Patient, Ophthalmic
• 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 Surgical Devices (DSD); General Surgery Devices Branch One - Light Based/Laser (GSDB1)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 878.4370 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: HMT
• 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: 2820
• Device: Drape, Patient, Ophthalmic
• Product Code: HMT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Surgical Drape And Drape Accessories.
• CFR Regulation Number: 878.4370 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research, Ltd.	II	Sep-24-2014

TPLC Last Update: 2019-04-02 20:19:17