Recognized Consensus Standards

Recognition List Number: 025 Publication Date: 10/04/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 5-62: ANSI / ASQ Z1.4-2008, Sampling Procedures and Tables for Inspection by Attributes. (General)

Date of Standard: 2008. 

Addresses of Standards Organizations:

  American National Standards Institute (ANSI)

  25 West 43rd Street

  4th Floor

  New York, NY 10036

  American Society for Quality (ASQ)

  600 North Plankinton Avenue

  Milwaukee, WI 53203

CDRH Offices and Divisions Associated with Recognized Standards:

(1) OFFICE OF DEVICE EVALUATION (ODE)

(2) OFFICE OF COMPLIANCE (OC)

Devices Affected:

All Medical Devices

Processes Affected:

510(k), PMA, IDE, PDP, HDE

Type of Standard:

 National, Horizontal

Extent of Recognition:

Use of all Single, Double and Multiple sampling plans according to the standard's switching rules to make acceptance/rejection decisions on a continuous stream of lots for a specified Acceptance Quality Limit (AQL).

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§878.4460	Surgeon'S Gloves	Class 1	KGO
Regulation Number	Device Name	Device Class	Product Code
§880.6250	Latex Patient Examination Glove	Class 1	LYY
§880.6250	Patient Examination Glove	Class 1	FMC
§880.6250	Polymer Patient Examination Glove	Class 1	LZA
§880.6250	Vinyl Patient Examination Glove	Class 1	LYZ
Regulation Number	Device Name	Device Class	Product Code
§884.5300	Condom	Class 2	HIS
§884.5300	Condom, Synthetic	Class 2	MOL
Regulation Number	Device Name	Device Class	Product Code
§884.5310	Condom With Nonoxynol-9	Class 2	LTZ

Relevant Guidance:

There is no relevant guidance developed at this time.

FDA Technical Contact:

  William MacFarland

  FDA/CDRH/OC

  10903 New Hampshire Avenue Building 66, Room 1108

  Silver Spring MD 20993

  301/796-5547

  Email: william.macfarland@fda.hhs.gov