(64 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 5250-0064
This document describes the acceptance criteria and the study conducted to demonstrate that the medical device in question, "FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, White (Non-colored)," meets these criteria.
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 | <10mg/dm² |
| Biocompatibility | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| 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. However, it references established industry standards from ASTM and FDA regulations, which typically prescribe statistically significant sample sizes for their respective testing methodologies.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The testing was conducted by the manufacturer, Shijiazhuang Fuguan Plastic Products Co., Ltd., which is based in Hebei Province, P.R. China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The acceptance criteria are based on established regulatory standards (21 CFR 800.20) and industry standards (ASTM D 5250-00e4, ASTM D6124-01, ISO10993-10). The device's performance was evaluated against these predefined objective criteria rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements against established standards, not on subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not applicable to the assessment of patient examination gloves. MRMC studies are typically used for diagnostic or screening devices where human interpretation is involved.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical medical device (gloves), not an algorithm or software. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The ground truth for evaluating the device's performance is based on established regulatory and industry standards. These standards define the acceptable physical, mechanical, and biocompatibility properties for patient examination gloves.
- ASTM D 5250-00e4: Standard Specification for Poly(Vinyl Chloride) Patient Examination Gloves. This standard dictates requirements for dimensions, physical properties, and powder amount.
- 21 CFR 800.20: This FDA regulation covers "Indirectly Heated Autoclaves," but in this context, it is referenced for "Freedom from pinholes," which is a specific test for barrier integrity.
- ASTM D 6124-01: Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
8. Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve AI algorithms that require a "training set." The testing performed is for product quality and compliance with standards.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
"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: K032907 ." (applicant leave blank)
NOV 2 0 2003
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 Fuguan Plastic Products Co., Ltd. |
|---|---|
| Submitter's address : | The Jia Village, Dahe County , Lu Quan City, Hebei Province,050204 P.R.China |
| Phone number : | (86) 311 229 4202 |
| Fax number : | (86) 311 229 1575 |
| Name of contact person: | Chun-jing AN |
| Date the summary was prepared: | 12 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: | FUGUAN (Brand) Powdered Vinyl Patient ExaminationGlovesOther 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 5250-0064.
Predicate device : powdered synthetic vinyl patient examination gloves, Shijiazhuang Eversharp Plastics Products Co., Ltd. K011884 .
[(a)(4)] A description of the device
Page 1of 2 Section C
{1}------------------------------------------------
KD22901
Device Description : powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: powdered vinyl patient examination glove , white(noncolored) 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 inrabbits | <10mg/dm² |
| Passes | ||
| Dermal sensitization in theguinea pig | Not a Primary Skin Irritation | |
| 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 D5250-008, 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 FUGUAN (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 .
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Shijiazhuang Fuguan Plastic Products Company Limited C/O Mr. Chen Yuhong TUV Rheinland Beijing Office RM. 707. AVIC Bldg No.2 Dong San Huan Nan Road Chaovang District Beijing, 100022, P.R. China
Re: K032907
Trade/Device Name: Fuguan (Brand) powdered Vinyl Patient Examination Gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Product Code: LYZ Dated: September 12, 2003 Received: September 24, 2003
Dear Mr. Chen Yuhong:
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.
{3}------------------------------------------------
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 (OS) 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 iabeling 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,
Susan Quann
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
{4}------------------------------------------------
INDICATIONS FOR USE
Applicant: Shijiazhuang Fuguan Plastic Products Co., Ltd.
510(k) Number (if known): *
usuan Powdered Vinyl Patient Examination Gloves, White(Non-colored) Device Name;
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. Burnell
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_K0329
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
§ 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.