The Qingdao Shuang condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Description

This condom is made of a natural rubber latex, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip, and is designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600. This condom is lubricated with silicone.

AI/ML Overview

The provided document describes a 510(k) Notification for a Male Latex Condom and discusses its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria.

The 510(k) summary mentions that the device is "designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600." It also states "This condom has the same technological characteristics as the predicate condom identified above. The design of both products conforms with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex."

Based on this, the acceptance criteria would be those defined within these standards, and the study proving compliance would involve testing the condom's physical properties against the requirements of these standards. However, the specific results of such tests, sample sizes, ground truth establishment, or expert involvement are not detailed in this document.

Therefore, I cannot populate all the requested sections with information directly from the provided text. I will indicate where information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical Properties (e.g., burst pressure, elongation, freedom from holes, dimensions) (as per ASTM D3492, ISO 4074, EN 600)	The document states the device "conforms to established national and international voluntary standards including ASTM D3492, ISO 4074, and EN 600." No specific numerical performance values are provided.

2. Sample size used for the test set and the data provenance

Sample size: Not specified in the provided document.
Data provenance: Not specified in the provided document. Testing against standards would typically involve prospective testing of manufactured batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (number and qualifications of experts) is not typically relevant for the performance testing of a physical product like a condom against established engineering standards. The ground truth would be based on the objective measurements and specifications defined in the standards themselves.

4. Adjudication method for the test set

Not applicable as the assessment is against objective physical standards, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a diagnostic device involving human reader interpretation or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The ground truth for device performance would be the objective specifications and limits outlined in the referenced voluntary standards (ASTM D3492, ISO 4074, EN 600) for male latex condoms. These standards define acceptable ranges for physical properties (e.g., burst volume, burst pressure, tensile strength, dimensions, freedom from holes).

8. The sample size for the training set

Not applicable. This is not a machine learning model; thus, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning model; thus, there is no "training set."

Summary

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SEP 2 1 2001

Abbreviated 510(k) Notification for a Male Latex Condom KOloGS3 Page 5 of 13

II. 510(k) Summary

Submitted By:	Quingdao Shuang Die Latex Production Co. Ltd.No. 103 Taidongyi RoadQingdao, ChinaTelephone: 213 383 9863 (US)
Contact Person:	Eli J. CarterConsultant1219 Little Creek RoadDurham, NC 27713Telephone: 919 544 4098	Michael ParkPresident, Import/ExportEC Plaza USA, Inc.3333 Wilshire Blvd.Los Angeles, CA 90010Telephone: 213 383 9863
Date Prepared:	August 8, 2001
Proprietary Name:	Various Brand Names
Common Name:	Latex Condom
Classification Name:	Condom (21 CFR 884.5300)
Predicate Device:	Thai Nippon Male Latex Condom510(k)# K994095
Description of Device:	This condom is made of a natural rubber latex, whichcompletely covers the erect penis with a closely fittedmembrane. This condom is straight-walled with a reservoirtip, and is designed to conform to established national andinternational voluntary standards including ASTM D3492,ISO 4074, and EN 600. This condom is lubricated withsilicone.
Intended Use of the Device:	This latex condom has the same intended use as the predicatecondom. The condom is used for contraception and forprophylactic purposes (to help prevent pregnancy and thetransmission of sexually transmitted diseases), including HIV.If properly used, this condom will help reduce the risk ofpregnancy without the serious side effects sometimesassociated with other contraceptive methods.
Technological Characteristics:	This condom has the same technological characteristics as thepredicate condom identified above. The design of bothproducts conforms with ASTM Latex Condom StandardD3492 and the condom is made of natural rubber latex.

. .

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2001

Oingdao Shuang Die Latex Production Co., Ltd. % Mr. Eli J. Carter Consultant to Qingdao Shuang 1219 Little Creek Road DURHAM NC 27713

Re: K012653

Trade/Device Name: Male Latex Condom Regulation Number:_21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: August 8, 2001 Received: August 13, 2001

Dear Mr. Carter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 - Mr. Eli J. Carter

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

Please be advised that, as of March 25, 1998. labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597,or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Evelinne

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Loi2ioS3

Information for a Male Latex Condom 510(k) Submission

Page 11 of 13

INDICATIONS FOR USE STATEMENT VII.

510(K) Number	Not Known
Device Name	Male Natural Rubber Latex Condom (Various Brand Names)
Indications for Use	The Qingdao Shuang condom is used for contraception and forprophylactic purposes (to help prevent pregnancy and thetransmission of sexually transmitted diseases).

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K012653

Over-the-Counter Use

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Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.