LogoFDA 510(k) Search
K Number
K982720
Device Name
H-RAY
Manufacturer
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
Date Cleared
1998-11-05

(93 days)

Product Code
LYZ80L
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 Description
Glove, Patient Examination, Vinyl Powder Free
More Information

Not Found

Not Found

No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.

No
The device is described as a glove intended to prevent contamination between healthcare personnel and patients, which is a barrier function, not a therapeutic one.

No
The device is a glove for preventing contamination, not for diagnosing medical conditions.

No

The device description clearly states it is a "Glove, Patient Examination, Vinyl Powder Free," which is a physical hardware device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic test performed in vitro (outside the body) on specimens.
  • Device Description: It's a patient examination glove. Gloves are physical barriers, not diagnostic tools.
  • Lack of IVD Characteristics: The description lacks any mention of:
    • Analyzing specimens (blood, urine, tissue, etc.)
    • Detecting or measuring substances in specimens
    • Providing information for diagnosis, monitoring, or screening

IVDs are devices used to examine specimens from the human body to provide information for diagnostic purposes. This glove does not fit that description.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

80LYZ

Device Description

Glove, Patient Examination, Vinyl Powder Free

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare and similar personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

0

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.

1

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

SPECSIZESMALLMEDIUMLARGEX-LARGETEST CODE
CIRCUMFERENCE
OF PALM (H/H)
(INCH)178
6-3/4210
7-3/4218
8-1/2230
9JIS-S-2045.5.9
TOTAL LENGTH
( $\pm$ 5H/H)240245245245JIS-S-2045.5.9
LENGTH OF
FINGERS (H/H)
THUMBS55576163JIS-2045.5.9
INDEX FINGER66707578
MIDDLE FINGER74818892
RING FINGER69747982
LITTLE FINGER54556062
CIRCUMFERENCE
FINGERS
THUMB63717883JIS-S-2045.5.9
INDEX FINGER56647074
MIDDLE FINGER59687276
RING FINGER56636973
LITTLE FINGER50576266
TENSILE STRENGTH
(MPa)Min.
10.0Min.
10.00Min.
10.00Min.
10.00JIS-2045.5.2
ELONGATION
(Min.)350%350%350%350%JIS-2045.5.2
WEIGHT (g/pc)7.08.09.09.5$\pm$ 0.2%
THICKNESSFinger Tip 0.08mm $\pm$ 0.02mm
Cuff 0.09mm $\pm$ 0.02mm
Palm 0.15mm $\pm$ 0.02mm
QUALITY
ASSURANCEUNDER 4% PINHOLE RATEFDA GLOVE 1000
HL WATER LEAK
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

2

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.

3

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 (301) 594-4692. 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 Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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

4

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

POWDER FREE Patient Examination Glove . Dovicc Namc: Vinyl

【 tions For Usc:

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