(49 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, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.
The provided document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)". This is a Class I medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information details the acceptance criteria and the methods used to prove the device meets these criteria.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Defined by ASTM D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Defined by ASTM D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Defined by 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Defined by ASTM D 5250-00e4 (specifically <10mg/dm2 for powder amount) | <10mg/dm2 |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO10993-10) | Not a Primary Skin Irritation Pass | Passes / Not a Primary Skin Irritation |
| Dermal sensitization in guinea pig (ISO10993-10) | Not a Dermal Sensitization Pass | Passes / Not a Dermal Sensitization |
Note: The document explicitly states "Meets" or "Passes" for most criteria, indicating successful adherence to the specified standards or thresholds. For powder amount, a specific value (<10mg/dm2) is given.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/algorithm-driven device. Instead, the device is a physical product (gloves) and its performance is evaluated against established physical and chemical standards. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) for data in the typical sense of AI/machine learning studies is not directly applicable here.
For the physical and chemical property tests, it's highly probable that samples from manufacturing batches were used. However, the exact sample sizes for each test (e.g., how many gloves were tested for pinholes, how many for dimensions, how many animals for biocompatibility) are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this device and study. The "ground truth" for the performance of these gloves is established by objective, standardized tests and measurements against published ASTM and CFR standards, not by expert consensus on clinical findings or images.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The performance of these gloves is determined through objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI systems where the performance of human readers with and without AI assistance is compared. This device is a patient examination glove, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone performance study was not done. This concept applies to AI algorithms and is not relevant for a physical medical device like examination gloves.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective, predefined standards and test methods. Specifically:
- ASTM standard D 5250-00e4: For dimensions, physical properties, and powder amount. This standard outlines measurable specifications and test procedures.
- 21 CFR 800.20: For freedom from pinholes. This regulation defines the acceptable quality level (AQL) for pinholes and the test method (water leak test).
- ISO10993-10: For biocompatibility (primary skin irritation and dermal sensitization). This standard specifies the in-vivo biological evaluation tests to assess potential adverse reactions.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" for this device, as it is a physical product, not an AI model requiring data for training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set.
{0}------------------------------------------------
SEP - 2 2005 Premarket Notification 【510(K)】 Summa
"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: ______________________________________________________________________________________________________________________________________________
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 : | SHIJIAZHUANG MANFUL LIGHT INDUSTRIALPRODUCTS CO., LTD | |
|---|---|---|
| Submitter's address : | NO.78 CANGSHI ROAD, JINZHOU CITY, HEBEI, 052260,P.R.CHINA | |
| Phone number : | (86)0311-4318269 | |
| Fax number : | (86)0311-4322592 | |
| Name of contact person: | Mr. Guo Huanqiang | |
| Date the summary was prepared: | 15 August 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,Colored(White, Yellow) |
|---|---|
| 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, yellow) that meets all of the requirements of ASTM standard D 5250-00-4.
Predicate device : Powdered Vinyl Patient Examination Gloves, Powdered Vinyl Patient Examination Gloves,K042120
[(a)(4)] A description of the device
Device Description : powdered vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-00-3.
{1}------------------------------------------------
Device Intended Use: powdered vinyl patient examination glove (white, yellow) 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, yell low) 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 inrabbits | <10mg/dm2 |
| Passes | ||
| Not a Primary Skin Irritation | ||
| Dermal sensitization in theguinea 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, yellow) meet requirements per ASTM D5250-0054, 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 Powdered Vinyl Patient Examination Gloves (White, yellow) neet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims .
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2005
Shijiazhuang Manful Light Industrial Products Co., Ltd. C/O Mr. Chu Xiaoan Room 1606 Bldg. 1. Jianxiangyuan No. 209 Bei Shi Huan Zhong Road Haidian District Beijing, CHINA 100083
Re: K051924/S001
Kost /24/2001
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: August 22, 2005 Received: August 22, 2005
Dear Mr. Xiaoan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becated by the device is substantially equivalent (for the relerenced above and nave decemblical to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseree pror to that have been reclassified in accordance with the provisions of Anticincine, of to devroes that having Act (Act) that do not require approval of a premarket inc Federal I ood, Drug, that Countine , therefore, market the device, subject to the general approval application (11.2 1). The general controls provisions of the Act include controls provisions of the rion from 2007 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 If your device is classified (see above) in the secured. Existing major regulations affecting (FMA), it may of subject to Sach addini Fleeteral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Oods to receint concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Mr. Xiaoan
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 mean that FDA nas made a decemmanon that your ministered by other Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You music comply with an the Fee s required (21 CFR Part 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 800); and i and listing (21 CFR Fall 807), laocimig (21 CFR Part 82), on (21 CFR Part 820); and if requirements as set form in the quality Systems (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 5 10(k)
19 a This letter will anow you to begin maneting your dence of your device to a a premarket notification. The I DA miding of basical on 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),
All and Career and Career and 10 Career and 10 companse the regulation If you desire specific advice for your de recolor at (240) 276-0115. Also, please note the regulation please contact the Office or Comphanes are (210) - 11 (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorination on Joan Copsumer Assistance at its toll-free Division of Sman 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syletta Y. Michael Orns.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control Center and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known):K051924
Device Name: Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)
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 × (21 CFR 801 Subpart C)
S, LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) urrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental De
510(k) Number: A 051924
§ 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.