(66 days)
Powdered vinyl 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.
powdered vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-004.
Acceptance Criteria and Study for Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves
This document summarizes the acceptance criteria and the study conducted to demonstrate that the Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves meet these criteria, as described in the provided 510(k) summary (K032783).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatibility - Primary Skin Irritation | Primary Skin Irritation in rabbits (Passes: Not a Primary Skin Irritation) | <10mg/dm2; Passes; Not a Primary Skin Irritation |
| Biocompatibility - Dermal Sensitization | Dermal sensitization in the guinea pig (Passes: Not a Dermal sensitization) | Passes; Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for the individual tests (e.g., number of gloves tested for dimensions, physical properties, or pinholes).
The data provenance is implicit: the tests were conducted by the manufacturer, Zibo Blue Sail Chemical Co., Ltd., presumably in P.R. China, to demonstrate compliance with the specified ASTM standards and FDA regulations. The studies appear to be retrospective in nature, as they involve testing a manufactured product against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device is based on objective, quantifiable physical and chemical parameters defined by established industry standards (ASTM) and federal regulations (CFR). There is no mention of human experts being used to establish a "ground truth" for the performance of the gloves beyond interpreting the results of standardized tests.
4. Adjudication Method for the Test Set
Not applicable. Since the tests are based on objective measurements against defined standard limits, an adjudication method for conflicting expert opinions is not relevant. The pass/fail criteria are directly derived from the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic or interpretive medical devices where human readers (e.g., radiologists) interpret images or data. Patient examination gloves are a physical barrier device, and their effectiveness is assessed through physical and biocompatibility testing, not through human interpretation of medical data.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a medical glove, not an algorithm or software. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply. The performance evaluation focuses on the physical and chemical characteristics of the glove itself.
7. Type of Ground Truth Used
The ground truth used for evaluating this device is based on objective, quantitative standards and regulatory requirements. Specifically:
- ASTM standards (D 5250-00e4 and presumably D6124-01): These standards define the acceptable ranges for physical properties (dimensions, tensile strength, elongation, puncture resistance) and powder amount.
- 21 CFR 800.20: This regulation defines the acceptable quality level (AQL) for freedom from pinholes (water leak test).
- ISO 10993-10: This international standard covers biological evaluation of medical devices, specifically for irritation and sensitization.
Essentially, the "ground truth" is defined by the pass/fail criteria specified within these published standards and regulations.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (medical glove), not an AI/ML algorithm or system that requires a "training set" in the context of machine learning. The manufacturing process is subject to quality control, but there is no "training set" of data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As established in point 8, there is no "training set" for this device. The manufacturing and testing processes follow established quality management systems and standard operating procedures to ensure consistent product quality, but this is distinct from establishing ground truth for machine learning training.
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C Summary
NOV 1 3 2003
"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: 1032783 ." (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Zibo Blue Sail Chemical Co., Ltd |
|---|---|
| Submitter's address : | Qilu Chemical Industrial Area, Zibo City, Shandong Province, 255414, P.R.China |
| Phone number : | (86)533-7486199 |
| Fax number : | (86)533-7481177 |
| Name of contact person: | Liu Wenjing |
| Date the summary was prepared: | 3 September 2003 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powdered Vinyl Patient Examination Gloves, White (non-colored) |
|---|---|
| Proprietary/Trade name: | Blue Sail (Brand) Powdered Vinyl Patient Examination GlovesOther clients private labeling |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powdered vinyl patient examination gloves , white (non-colored) that meets all of the requirements of ASTM standard D 5250-0064.
Predicate device : powdered synthetic vinyl patient examination gloves, Shijiazhuang Eversharp Plastics Products Co., Ltd. K011884 .
[(a)(4)} A description of the device
Device Description : powdered vinyl patient examination gloves, white (non-colored) that meets all of the requirements of ASTM standard D 5250-004.
Page 1of 2 Section C
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient examination glove, white (non-colored) 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powdered vinyl patient examination gloves, white (non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4. | Meets |
| Physical Properties | ASTM standard D 5250-00e4. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatability | Primary Skin Irritation in rabbits | <10mg/dm2PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea pig | PassesNot a Dermal sensitization |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powdered vinyl patient examination gloves , white (non-colored) meet requirements per ASTM D5250-0064, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves , White (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Zibo Blue Sail Chemical Corporation Limited C/O Ms. Yuhong Chen Tuv Rheinland Beijing Office Rm 707, AVIC Bldg, No. 2 No. 2 Dong San Huan Nan Road Chaoyang District, Beijing, 100022, P.R. CHINA
Re: K032783
Trade/Device Name: Blue Sail (Brand) Powdered Vinyl Patient Examination gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 3, 2003 Received: September 8, 2003
Dear Ms. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Yuhong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Chue L
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
Applicant: Zibo Blue Sail Chemical Co.,Ltd.
510(k) Number (if known): * KO32783 Blue Sail (Brand) Device Name: Powdered Vinyl Patient Examination Gloves, White(non-colored)
Indications For Use:
Powdered vinyl 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.
Susanna F. Bourud
nesthesiology, General Hospital, Infection Control. Dental
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.