H-RAY

K982720 · Shijiazhuang Hongray Plastic Products Co., Ltd. · LYZ · Nov 5, 1998 · General Hospital

Device Facts

• Record ID: K982720
• Device Name: H-RAY
• Applicant: Shijiazhuang Hongray Plastic Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Nov 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

This glove is to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Vinyl patient examination glove; powder-free; ambidextrous; worn on hands of healthcare personnel. Acts as physical barrier to prevent cross-contamination between wearer and patient body, fluids, waste, or environment. Used in clinical settings. Provides protection during patient examinations.

Clinical Evidence

Bench testing only. Biocompatibility testing included Primary Dermal Irritation in rabbits and Guinea Pig Sensitization (Buehler). Physical testing included tensile strength (min 10.0 MPa), elongation (min 350%), and water leak testing (pinhole rate < 4%) per ASTM D5250-92 and JIS-S-2045.5.9 standards.

Technological Characteristics

Vinyl material; powder-free; ambidextrous; 10-inch length. Thickness: 0.08mm (finger tip), 0.09mm (cuff), 0.15mm (palm). Tensile strength min 10.0 MPa; elongation min 350%. Complies with ASTM D5250-92 and JIS-S-2045.5.9 specifications.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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Image /page/0/Figure/0 description: This image is a document from Shijiazhuang HongRay Plastic Products Co., Ltd. dated November 5, 1998. It includes the company's head office and factory address in Shijiazhuang, China, as well as a branch office in Taipei, Taiwan. The document also lists contact information for the applicant, Mr. Lin Chin Yu, and the agent, Mr. Don Morris, along with phone and fax numbers.

- 3.0 Device Class: 1 Product Code: 80LYZ
- 4.0 Specification: Glove, Patient Examination, Vinyl Powder Free meets all of the requirements of ASTM Standard D5250-92
- 5.0 Device Description: Glove, Patient Examination, Vinyl Powder Free
- 6 o Tntended User. I glove is worn on the hand of healthcare and ciriller personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
- 7.0 Inner Surface: Powder Free
- 8.0 Biocompatibility Testing: Primary Dermal Irritation in Rabbits and Guinea Pig Sensitization (Buehler) by Consumer Products Testing Co., USA.

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Image /page/1/Figure/0 description: This image shows the letterhead for Shijiazhuang HongRay Plastic Products Co., Ltd. The letterhead includes the company's name, address, phone number, fax number, and telex number. The head office is located at No. 135 XUA HUA WEST ROAD, SHIJIAZHUANG CITY, and the factory is located in HEBEI PROVINCE, CHINA. The branch office is located at RM3, 5TH FL., NO. 76 FUSHING SOUTH ROAD, SECTION 1, TAIPEI, TAIWAN.

## 510(K) SUMMARY

## Page 2 of 2

## 9.0 Quality Characteristics

| SPEC | SIZE | SMALL | MEDIUM | LARGE | X-LARGE | TEST CODE | |
|------------------------------------------|------|----------------------------------------------------------------------------------------|---------------|---------------|---------------|----------------|-----------------------------------------|
| CIRCUMFERENCE<br>OF PALM (H/H)<br>(INCH) | | 178<br>6-3/4 | 210<br>7-3/4 | 218<br>8-1/2 | 230<br>9 | JIS-S-2045.5.9 | |
| TOTAL LENGTH<br>( $\pm$ 5H/H) | | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 | |
| LENGTH OF<br>FINGERS (H/H)<br>THUMBS | | 55 | 57 | 61 | 63 | JIS-2045.5.9 | |
| INDEX FINGER | | 66 | 70 | 75 | 78 | | |
| MIDDLE FINGER | | 74 | 81 | 88 | 92 | | |
| RING FINGER | | 69 | 74 | 79 | 82 | | |
| LITTLE FINGER | | 54 | 55 | 60 | 62 | | |
| CIRCUMFERENCE<br>FINGERS<br>THUMB | | 63 | 71 | 78 | 83 | JIS-S-2045.5.9 | |
| INDEX FINGER | | 56 | 64 | 70 | 74 | | |
| MIDDLE FINGER | | 59 | 68 | 72 | 76 | | |
| RING FINGER | | 56 | 63 | 69 | 73 | | |
| LITTLE FINGER | | 50 | 57 | 62 | 66 | | |
| TENSILE STRENGTH<br>(MPa) | | Min.<br>10.0 | Min.<br>10.00 | Min.<br>10.00 | Min.<br>10.00 | JIS-2045.5.2 | |
| ELONGATION<br>(Min.) | | 350% | 350% | 350% | 350% | JIS-2045.5.2 | |
| WEIGHT (g/pc) | | 7.0 | 8.0 | 9.0 | 9.5 | $\pm$ 0.2% | |
| THICKNESS | | Finger Tip 0.08mm $\pm$ 0.02mm<br>Cuff 0.09mm $\pm$ 0.02mm<br>Palm 0.15mm $\pm$ 0.02mm | | | | | |
| QUALITY<br>ASSURANCE | | UNDER 4% PINHOLE RATE | | | | | FDA GLOVE 1000<br>HL WATER LEAK<br>TEST |

- SPECIFICATION OF VIRYL GLOVES ( A K B I D E X T R O U S )
Powder Free 10"

- 0.0 Conclusion: Shinjiazhuang Hongray Plastic Products Co., Ltd. Vinyl Patient Examination Gloves meet ASTM Standards - meets pinhole requirements and labeling claims. ASTM D5250-92

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head in profile, with three curved lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1998 NOV

Mr. Lin Chin Yu Shijiazhuang Hongray Plastic Products Company, Limited No. 135 Xin-Hua West Road Shijiazhuang, CHINA

Re: K982720 H-Ray Non-sterile Powder-Free Vinyl Patient Trade Name: Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 19, 1998 October 20, 1998 Received:

Dear Mr. Lin Chin Yu:

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 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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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.

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Page 2 -- Mr. Lin Chin Yu

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acinding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

> Sincerely yours, Susen Kinner

ra Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K982120 |
|---------------------------|---------|
|---------------------------|---------|

POWDER FREE Patient Examination Glove . Dovicc Namc: Vinyl

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This glove is to be worn on the hand of healthcare and similar This glove is to be worn on the name of noalehours wealthcare personnel.
personnel the the fluids, waste or environment. personnel co prevent concamination waste or environment.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

scription Use - 21 CFR 80 1.109)

OR Over-The-Counter Use (Optional Formal 1-2-96) (Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number