(93 days)
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.
Glove, Patient Examination, Vinyl Powder Free
The provided document describes the acceptance criteria and performance data for "Shijiazhuang HongRay Plastic Products Co., Ltd. Vinyl Patient Examination Gloves (Powder Free)."
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| SPECIFICATION CATEGORY | SPEC (Acceptance Criteria) | REPORTED DEVICE PERFORMANCE (Example for size "Small" where applicable) | Test Code |
|---|---|---|---|
| Material & Physical Properties | |||
| Standard Compliance | Meets all requirements of ASTM Standard D5250-92 | Meets ASTM Standards | - |
| Pinhole Rate | Under 4% pinhole rate | Meets pinhole requirements (Implied to be under 4%) | FDA GLOVE 1000 HL WATER LEAK TEST |
| Tensile Strength (MPa) | Min. 10.0 MPa (for all sizes) | Min. 10.0 MPa (for Small, Medium, Large, X-Large) | JIS-2045.5.2 |
| Elongation (Min.) | 350% (for all sizes) | 350% (for Small, Medium, Large, X-Large) | JIS-2045.5.2 |
| Thickness (Finger Tip) | 0.08mm ± 0.02mm | 0.08mm ± 0.02mm | - |
| Thickness (Cuff) | 0.09mm ± 0.02mm | 0.09mm ± 0.02mm | - |
| Thickness (Palm) | 0.15mm ± 0.02mm | 0.15mm ± 0.02mm | - |
| Dimensional Specifications | |||
| Circumference of Palm (inch) | 6-3/4 (Small), 7-3/4 (Medium), 8-1/2 (Large), 9 (X-Large) | 6-3/4 (Small), 7-3/4 (Medium), 8-1/2 (Large), 9 (X-Large) | JIS-S-2045.5.9 |
| Total Length (± 5H/H) | 240 (Small), 245 (Medium, Large, X-Large) | 240 (Small), 245 (Medium, Large, X-Large) | JIS-S-2045.5.9 |
| Length of Thumbs (H/H) | 55 (Small), 57 (Medium), 61 (Large), 63 (X-Large) | 55 (Small), 57 (Medium), 61 (Large), 63 (X-Large) | JIS-2045.5.9 |
| Length of Index Finger (H/H) | 66 (Small), 70 (Medium), 75 (Large), 78 (X-Large) | 66 (Small), 70 (Medium), 75 (Large), 78 (X-Large) | - |
| Length of Middle Finger (H/H) | 74 (Small), 81 (Medium), 88 (Large), 92 (X-Large) | 74 (Small), 81 (Medium), 88 (Large), 92 (X-Large) | - |
| Length of Ring Finger (H/H) | 69 (Small), 74 (Medium), 79 (Large), 82 (X-Large) | 69 (Small), 74 (Medium), 79 (Large), 82 (X-Large) | - |
| Length of Little Finger (H/H) | 54 (Small), 55 (Medium), 60 (Large), 62 (X-Large) | 54 (Small), 55 (Medium), 60 (Large), 62 (X-Large) | - |
| Circumference of Thumb (H/H) | 63 (Small), 71 (Medium), 78 (Large), 83 (X-Large) | 63 (Small), 71 (Medium), 78 (Large), 83 (X-Large) | JIS-S-2045.5.9 |
| Circumference of Index Finger (H/H) | 56 (Small), 64 (Medium), 70 (Large), 74 (X-Large) | 56 (Small), 64 (Medium), 70 (Large), 74 (X-Large) | - |
| Circumference of Middle Finger (H/H) | 59 (Small), 68 (Medium), 72 (Large), 76 (X-Large) | 59 (Small), 68 (Medium), 72 (Large), 76 (X-Large) | - |
| Circumference of Ring Finger (H/H) | 56 (Small), 63 (Medium), 69 (Large), 73 (X-Large) | 56 (Small), 63 (Medium), 69 (Large), 73 (X-Large) | - |
| Circumference of Little Finger (H/H) | 50 (Small), 57 (Medium), 62 (Large), 66 (X-Large) | 50 (Small), 57 (Medium), 62 (Large), 66 (X-Large) | - |
| Other | |||
| Weight (g/pc) | 7.0 (Small), 8.0 (Medium), 9.0 (Large), 9.5 (X-Large) ± 0.2% | 7.0 (Small), 8.0 (Medium), 9.0 (Large), 9.5 (X-Large) ± 0.2% | - |
| Inner Surface | Powder Free | Powder Free | - |
| Biocompatibility | Primary Dermal Irritation and Guinea Pig Sensitization | Performed by Consumer Products Testing Co., USA. (Results not explicitly stated, but implies acceptance) | - |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided documents. The specifications are listed for four sizes (Small, Medium, Large, X-Large), implying testing across these different sizes. For quality assurance like "Pinhole Rate," it mentions "FDA GLOVE 1000 HL WATER LEAK TEST," suggesting testing a sample of 1000 gloves but not specifying if this is the sample size for the regulatory submission itself.
- Data Provenance: The document does not explicitly state "test set" data provenance for all tests. The manufacturing location is Shijiazhuang, China. Biocompatibility testing was conducted by "Consumer Products Testing Co., USA." It's retrospective testing of manufactured products to ensure compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a medical glove, and the "ground truth" is established through physical and chemical testing against established standards (e.g., ASTM, JIS), not through expert interpretation of images or clinical data.
4. Adjudication method for the test set:
This information is not applicable for physical and biocompatibility testing of a medical glove. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving image interpretation or clinical expert review.
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:
This is not applicable. The device is a patient examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a patient examination glove, not a standalone algorithm.
7. The type of ground truth used:
The ground truth is established by industry standards and test methods. Specifically:
- ASTM Standard D5250-92
- JIS-S-2045 (various sections for dimensions and tensile properties)
- FDA GLOVE 1000 HL WATER LEAK TEST for pinholes
- Biocompatibility methods (Primary Dermal Irritation in Rabbits and Guinea Pig Sensitization (Buehler))
8. The sample size for the training set:
This information is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.
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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 | |
|---|---|---|---|---|---|---|---|
| CIRCUMFERENCEOF PALM (H/H)(INCH) | 1786-3/4 | 2107-3/4 | 2188-1/2 | 2309 | JIS-S-2045.5.9 | ||
| TOTAL LENGTH( $\pm$ 5H/H) | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 | ||
| LENGTH OFFINGERS (H/H)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 | |||
| CIRCUMFERENCEFINGERSTHUMB | 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(MPa) | Min.10.0 | Min.10.00 | Min.10.00 | Min.10.00 | JIS-2045.5.2 | ||
| ELONGATION(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 $\pm$ 0.02mmCuff 0.09mm $\pm$ 0.02mmPalm 0.15mm $\pm$ 0.02mm | ||||||
| QUALITYASSURANCE | UNDER 4% PINHOLE RATE | FDA GLOVE 1000HL WATER LEAKTEST |
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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 (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
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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
§ 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.