(47 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 5250-00-4
Here's an analysis of the provided text regarding acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, White (Non-colored)":
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00c4 | <10mg/dm² |
| Biocompatibility (Primary Skin Irritation) | ISO10993-10 (via "Primary Skin Irritation in rabbits") | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | ISO10993-10 (via "Dermal sensitization in the guinea pig") | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). However, the tests are conducted in accordance with referenced standards (ASTM D 5250-00c4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards typically specify sample sizes or methodologies for such testing.
The data provenance is not specified beyond "Hebei Manful Import & Export Co., Ltd." as the submitter, located in China. The studies are non-clinical (laboratory testing) and are retrospective in the sense that they were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided. For non-clinical, objective performance tests like those conducted for examination gloves (dimensional, physical properties, pinholes, powder amount), the "ground truth" is typically established by laboratory measurements against defined standards, rather than expert consensus on subjective findings. For biocompatibility, the ground truth is established by the observed biological response in animal models, interpreted by qualified toxicologists or study directors, though their number and specific qualifications are not detailed here.
4. Adjudication Method for the Test Set
Not applicable for these types of non-clinical performance and biocompatibility studies. The results are typically objective measurements or observations against predefined pass/fail criteria according to the referenced standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Examination gloves are medical devices with objective performance criteria.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against the specified standards without human interaction influencing the device's function or interpretation of its output. The device itself (the glove) is not an algorithm, so "algorithm only" is not directly applicable. However, its physical characteristics and biological safety were tested in an isolated manner.
7. Type of Ground Truth Used
The ground truth used for these studies is based on:
- Defined Standards: For dimensions, physical properties, powder amount, and freedom from pinholes, the "ground truth" is adherence to the specified ASTM and CFR standards with their quantitative limits.
- Laboratory Observations/Measurements: For biocompatibility, the ground truth is established through observed biological responses in animal models (e.g., presence or absence of irritation or sensitization), as interpreted by testing personnel/toxicologists following the ISO standard.
8. Sample Size for the Training Set
Not applicable. This device is an examination glove, not an AI/ML algorithm or a device that requires a "training set" in the context of machine learning. The studies described are performance and safety tests, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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C Summary
JUN 2 0 2005
"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: _ 05 (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the Iland). The sunmary contains on the fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | HEBEI MANFUL IMPORT & EXPORT CO., LTD | |
|---|---|---|
| Submitter's address : | NO.58 TONGDA ROAD, JINZHOU CITY, HEBEIPROVINCE, 052260, P.R.CHINA | |
| Phone number : | (86) 311-4338239 | |
| Fax number : | (86) 311-4338239 | |
| Name of contact person: | Ms. Yanchai Zhang | |
| Date the summary was prepared: | 06 April 2005 |
[(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: | 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: | LYZ |
[(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 5250-00"4
Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.
[(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 5250-00-4
Section C Page 1of 2
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[(a)(5)] The summary describes the intended use of the device
Device Intended lise: 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 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00c4 | <10mg/dm² |
| Biocompatability | Primary Skin Irritation in rabbits | Passes |
| Not a Primary Skin Irritation | ||
| Dermal sensitization in the guinea pig | Passes | |
| Not 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 D5250-00", 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 and clinical 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 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 U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
JUN 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Yanchai Zhang General Manager Hebei Manful Import & Export Company Limited No. 58, Tongda Road Jinzhou City, Hebei CHINA 052260
Re: K051154
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, White (Non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: April 6, 2005 Received: May 4, 2005
Dear Ms. Zhang:
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 - Ms. Zhang
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 vour 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Syltie y. Michael Dmd.
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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INDICATIONS FOR USE
Applicant: HEBEI MANFUL IMPORT & EXPORT CO., LTD
510(k) Number (if known):_*
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shade H. Murphy, MD 4/17/15
Page 1 of
nesthesiolog General Hospital ntrol De
510(k) Number. K031154
§ 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.