(29 days)
Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material .intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
The provided document describes the acceptance criteria and performance of "Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored)" manufactured by Hongxin Plastic Products Co.,Ltd. It's important to note that this is a medical device (gloves), not an AI algorithm, so many of the questions related to AI studies (like MRMC studies, training sets, expert ground truth for imaging, etc.) are not applicable.
Here's the information extracted and formatted according to your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 | Meets (<2mg/glove) |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in rabbits (ISO 10993-10) | Passes (Not a Primary Skin Irritation) |
| Biocompatibility: Dermal Sensitization | Dermal sensitization in the guinea pig (ISO 10993-10) | Passes (Not a Dermal Sensitization) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an algorithmic evaluation. The performance criteria are based on standardized tests for medical gloves. Sample sizes for these tests are typically defined within the respective ASTM and ISO standards (e.g., number of gloves tested for pinholes, number of rabbits for irritation tests). The document does not provide these specific sample sizes.
Data Provenance: The tests were conducted by the manufacturer to demonstrate compliance with the specified standards. The country of origin of the data is not explicitly stated beyond the manufacturer being in China. The data would be considered prospective as it's generated through testing the manufactured product according to established protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical medical product (gloves) and not an AI algorithm requiring expert adjudication for ground truth. The "ground truth" here is determined by objective measurements and tests against established physical and biological standards. For biocompatibility tests (like skin irritation), qualified laboratory personnel would conduct and interpret the results to determine "passes" or "fails" against defined criteria, but these are not "experts establishing ground truth" in the sense of medical image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical medical device. Performance is determined by test results against predefined criteria in the standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements and laboratory tests defined by:
- ASTM standards: For dimensions, physical properties, and powder residue.
- 21 CFR 800.20: For freedom from pinholes.
- ISO 10993-10: For biocompatibility (primary skin irritation and dermal sensitization).
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
{0}------------------------------------------------
MAR - 6 2012
Section C 510(k) Summary (21 CFR 807.92)
510(K) Summary
"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: 4203588
Premarket Notification [510(k)] Summary
| Submitter's name : | Hongxin Plastic Products Co.,Ltd. |
|---|---|
| Submitter's address : | No. 899-1 Hengtong Road, Zhoucun, Zibo, Shandong,255300 China |
| Phone number : | 0086-13831119188 |
| Fax number : | 0086-311-84316178 |
| Name of contact person: | Mr.Guan Zhenfeng |
| Date the summary was prepared: | 2012-01-23 |
| Device Name: | Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored). |
| Common Name: | Other clients private labeling. Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
Class I* Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM D 5250-06 e1.
Predicate device: Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
Device Description: Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material .intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
{1}------------------------------------------------
Device Intended Use (Indication for use): Powdered Free Vinyl Patient Examination Gloves, Clear (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 summary of the technological characteristics of new device compared to the predicate device.
The Powdered Free Vinyl Patient Examination Gloves, Clear (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 5250-06 el. | Meets |
| Physical Properties | ASTM standard D 5250-06 el. | Meets |
| Freedomfrompinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 eland D6124-06 | Meets<2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsISO 10993-10 | PassesNot a Primary SkinIrritation |
| . | Dermal sensitization in the guinea pigISO 10993-10 | PassesNot a Dermal sensitization |
A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence_
Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and ISO 10993-10: 2002/Amd.1:2006.
The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
The conclusions
C
It can be concluded that the Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.
It can be concluded that the Powdered Free Vinyl Patient Examination Gloves, Clear is as safe, as effective, and performs as well as the predicate device, (non-colored) Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
MAR - 6 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hongxin Plastic Products Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company, Limited RM 1606 Building, 1 Jian Xiang Yuan No. 209 Bei Si Huan Zhong Road Hai Di, Beijing China 100083
Re: K120358
Trade/Device Name: Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Gloves
Regulatory Class: I
Product Code: LYZ Dated: January 23, 2012. Received: February 6, 2012
Dear Mr. Xiaoan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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;
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Section B Indications for Use
INDICATIONS FOR USE
Hongxin Plastic Products Co.,Ltd. Applicant:
KIJO358 510(k) Number (if known): *
Device Name: Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications For Use:
Powdered Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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)
ະມະນັກຈະລັດ : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ం: ఎం. రావాలి కొత్త
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elysabeth F. Claussen-Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120358
Section B
Page 1/1
§ 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.