Finger Cot

Device Code: 2666

Product Code(s): LZB

Device Classification Information

• Device Type ID: 2666
• Device Name: Finger Cot
• Regulation Description: Non-powdered Patient Examination Glove.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Infection Control Devices Branch (INCB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 880.6250 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LZB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 6-176 ASTM D7103-06 (Reapproved 2013)
  Standard Guide For Assessment Of Medical Gloves
• 6-214 ASTM D6355-07 (Reapproved 2017)
  Standard Test Method For Human Repeat Insult Patch Testing Of Medical Gloves
• 6-355 ASTM D3772-15
  Standard Specification For Industrial Rubber Finger Cots
• 6-383 ASTM D6499-16
  Standard Test Method For The Immunological Measurement Of Antigenic Protein In Natural Rubber And Its Products
• 6-411 ASTM D6499-18
  Standard Test Method For Immunological Measurement Of Antigenic Protein In Hevea Natural Rubber (HNR) And Its Products

Total Product Life Cycle

• Device Type ID: 2666
• Device: Finger Cot
• Product Code: LZB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Non-powdered Patient Examination Glove.
• CFR Regulation Number: 880.6250 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	American Surgical Company	II	May-26-2016

TPLC Last Update: 2019-04-02 20:16:58