(44 days)
A glove is worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. A 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.
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Acceptance Criteria & Study Analysis for K974151: Vinyl Patient Examination Gloves
This device, the Shanghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves - Powdered, is a Class I medical device (21 CFR 880.6250) and is substantially equivalent to predicate devices. The safety and effectiveness are established through compliance with existing industry standards and specific tests, not through clinical trials in the traditional sense, as there are no specific claims requiring such studies (e.g., hypoallergenic).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Physical and Dimensions | ASTM-D-5250-92 | Meets requirements | Evaluated at Inspection Level S-2, AQL 4.0 |
| Barrier Integrity (Pinhole Defects) | FDA 1000 ml. Water Fill Test | Meets requirements | Evaluated with samplings of AQL 2.5, Inspection Level S-4 |
| Biocompatibility (Skin Irritation) | Not explicitly stated (standard test) | No primary skin irritant reactions | |
| Biocompatibility (Skin Sensitization) | Not explicitly stated (standard test) | No sensitization (allergic contact dermatitis) reactions | |
| Manufacturing Quality | FDA's Good Manufacturing Practices (GMPs) | Operates in compliance with GMPs | Confirms adherence to quality systems |
| Labeling | Applicable CFR 21 labeling requirements | Conforms fully | No special labeling claims (e.g., hypoallergenic) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Physical and Dimensions: The document states "Inspection Level S-2, AQL 4.0". This refers to attributes sampling plans defined in standards like ISO 2859 (or MIL-STD-105E from which it is derived).
- AQL (Acceptable Quality Level) 4.0: This means that the statistical sampling plan is designed to accept lots where the percentage of defective items is 4.0% or less.
- Inspection Level S-2: This is a special inspection level for circumstances where smaller sample sizes are desired, usually for testing that is destructive or expensive, while still providing some protection. The exact sample size would depend on the batch size, but for S-2, it would be significantly smaller than general inspection levels.
- Barrier Integrity (Pinhole Defects): The document states "samplings of AQL 2.5, Inspection Level S-4".
- AQL 2.5: This means the sampling plan is designed to accept lots where the percentage of defective items is 2.5% or less.
- Inspection Level S-4: Similar to S-2, this is a special inspection level for reduced sample sizes.
- Biocompatibility: No specific sample sizes for these tests are provided in the summary. Standardized tests (e.g., ISO 10993 series which often includes these tests) would typically specify the number of animals or human subjects (for patch tests) required, but the summary only provides the results.
- Data Provenance: The device is manufactured by Shanghai Super Gloves Co., Ltd. in Shanghai, China. The testing was conducted by the manufacturer, or by a testing laboratory on behalf of the manufacturer, to demonstrate compliance with the stated standards. The document does not specify if the data is retrospective or prospective, but given it's for a 510(k) submission, it would reflect tests performed for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable in the traditional sense for this device.
- For these types of devices (examination gloves), "ground truth" is established by adherence to recognized industry standards (ASTM-D-5250-92 for physical properties, FDA 1000 ml water fill test for pinholes, and general biocompatibility testing standards). The "experts" involved are the certified testing laboratories and their personnel who conduct these standardized tests according to established protocols and interpret the results against the defined acceptance criteria.
- There would not be a panel of human experts establishing a subjective "ground truth" for each glove.
4. Adjudication Method for the Test Set
- Not Applicable. As "ground truth" is based on objective, standardized tests against specified criteria, there is no need for expert adjudication. The tests yield definitive results (e.g., pass/fail for pinholes, quantitative measurements for physical properties, presence/absence of irritation for biocompatibility) which are then compared directly to the acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not relevant or applicable for an examination glove. MRMC studies are typically used to evaluate diagnostic imaging devices or algorithms where human readers interpret medical images.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is not an algorithmic or AI-enabled device. Its performance is intrinsic to its physical and chemical properties.
7. Type of Ground Truth Used
- Objective Test Results against Established Standards: The ground truth for this device is based on objective measurements and observations derived from standardized tests. Examples include:
- Physical Properties: Measurements of dimensions, tensile strength, elongation, etc., compared against the specifications in ASTM-D-5250-92.
- Pinhole Detection: Direct observation using the FDA 1000 ml Water Fill Test.
- Biocompatibility: Clinical observation of skin reactions in standardized animal or human patch tests, interpreted against established criteria for irritation and sensitization.
- The "ground truth" here is the direct, measurable compliance with these recognized benchmarks.
8. Sample Size for the Training Set
- Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The manufacturing process is designed to consistently produce gloves that meet the specifications, and quality control sampling is an ongoing process, not a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set exists for this device.
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ATTACHMENT B
DEC I 8 1997
510 (K) SUMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510 (k) number is: Kallyl 61
1. Submitter's Identification:
Ms. Lee Hung Yun-Shan Shanghai Super Gloves Co., Ltd. No. 4, Tingwei Road, Zhuhang Zhen Jinshan County, Shanghai, China
Date Summary Prepared: October 30, 1997
2. Name of the Device:
Shanghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves - Powdered
3. Predicate Device Information:
Sunmax Enterprise Shanghai Vinyl Patient Examination Gloves, K#960746 Cheer & Merit Vinyl Patient Examination Gloves, K#941809
4.
マ Device Description:
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
5. Intended Use:
1
of healthcare and similar is worn on the hand A glove between healthcare to prevent contamination personnel personnel and the patient's body , fluids, waste or environment.
ર . Comparison to Predicate Devices:
Shanghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves-Powdered, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Vinyl Patient Examination Glove and the Cheer & Merit Patient Examination Glove.
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ATTACHMENT B
- 2 -
Discussion of Non-Clinical Tests Performed for Determination 7. of Substantial Equivalence are as follows:
The standards used for Shanghai Super Gloves Co., Ltd. glove production are based on ASTM-D-5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on qloves, Inspection Level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
Shanghai Super Gloves Co., Ltd. operates in compliance with FDA's GMPs.
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Shanqhai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves conform fully to ASTM-D-5250-92 standards as well as references, and, meets pinhole FDA applicable CFR 21 labeling biocompatibility requirements and requirements, claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Shanghai Super Gloves Company, Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Re : K974151 Vinyl Patient Examination Gloves (Powdered) Trade Name: Requlatory Class: I Product Code: LYZ October 30, 1997 Dated: Received: November 4, 1997
Dear Ms. Goldstein-Falk:
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, 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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
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Paqe 2 - Ms. Goldstein-Falk
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 leqally 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A 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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ATTACHMENT A Page_1 _of__1
510(k) Number (if known): K974151
Shanghai Super Gloves Co., Ltd. Device Name:___ Viny1 Patient Examination Gloves-Powdered Indications For Use:
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|--|
Chin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K974151 |
|---|---|
| --------------- | --------- |
Prescription Use (Per 21 CFR 801.109)
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CR
Over-The-Counter Use_
(Optional Format 1-2-96)
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§ 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.