(181 days)
Powder free 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.
Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
Here's a breakdown of the requested information based on the provided 510(k) summary for the Powder-free Vinyl Patient Examination Gloves, Colored (Yellow).
It's important to note that this document is for a Class I medical device (patient examination gloves). For devices of this classification, the regulatory requirements are generally less stringent compared to higher-risk devices, and often the "studies" primarily involve adherence to recognized standards rather than complex clinical trials or AI performance evaluations.
Here is the requested information:
1. Table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-01 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | ISO10993-10 (Primary Skin Irritation in rabbits) | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | ISO10993-10 (Dermal sensitization in the guinea pig) | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state specific sample sizes for each test in the acceptance criteria table. However, it references ASTM standard D 5250-06, 21 CFR 800.20, ASTM D6124-01, and ISO10993-10. These standards typically specify the appropriate sampling plans and methodologies for testing.
- Data Provenance: The document does not specify the country of origin of the data. It's likely that the testing was conducted by the manufacturer (Tangshan Kangyuan Glove Co., Ltd. in China) or a contracted lab. The testing for a device of this nature is generally retrospective in the sense that batches of manufactured gloves are sampled and tested according to the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The concept of "ground truth established by experts" is not directly applicable in the context of testing these types of medical gloves. The performance of these gloves is assessed against objective physical and chemical standards rather than subjective expert interpretation.
- Experts: N/A for establishing "ground truth" as it's typically understood in AI/clinical studies. The "experts" in this context would be the technicians and scientists performing the standard-based tests and interpreting the results according to the specified criteria. Their qualifications would be in laboratory testing, materials science, or related fields, with expertise in executing the cited ASTM, CFR, and ISO standards.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies where subjective interpretations (e.g., image readings) need consensus. For objective physical and chemical tests on gloves, the results are typically quantitative or directly pass/fail according to the standard, not requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiology AI), to evaluate how AI assistance impacts reader performance. It is not applicable to patient examination gloves.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical product (gloves), not an AI algorithm. Therefore, the concept of algorithm-only performance does not apply.
7. The type of ground truth used
The "ground truth" for this device's performance is based on objective measurements and assessments against established industry standards and regulations. This includes:
- ASTM D 5250-06: Standard Specification for Poly(vinyl chloride) Patient Examination Gloves. This standard dictates physical properties, dimensions, and other performance characteristics.
- 21 CFR 800.20: FDA regulation concerning the water leak test (freedom from pinholes) for medical gloves.
- ASTM D6124-01: 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 (for biocompatibility).
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train an AI model. This device is not an AI algorithm or software and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
510(K) Summary
1 |
"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: ______________________________________________________________________________________________________________________________________________ ." (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 : | TANGSHAN KANGYUAN GLOVE CO., LTD. |
|---|---|
| Submitter's address : | LINQING ROAD, LUANNAN, TANGSHAN, HEBEI,063503, CHINA |
| Phone number : | (86) 315-4169201 |
| Fax number : | (86) 315-4169311 |
| Name of contact person: | Mr. Zhang Liang |
| Date the summary was prepared: | Dec.30nd, 2009 |
[(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: | Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves |
| 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* powder free vinyl patient examination gloves , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06.
Predicate device : Powder-Free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .
[(a)(4)] A description of the device
Device Description : Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
{1}------------------------------------------------
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder-free Vinyl Patient Examination Gloves, Colored (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 powder free vinyl patient examination gloves, 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 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | Meets |
| Biocompatability | and D6124-01 | <2mg/glove |
| Primary Skin Irritation in rabbits | Passes | |
| Dermal sensitization in the guinea pig | Not a Primary Skin IrritationPassesNot 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 .
Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06, 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 Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims .
{2}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tangshan Kangyuan Glove Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1. Jianxing Yuan No. 209 Bei Si Huan Beijing China 100083
'JUL - 8 2010
Re: K100057
Trade/Device Name: Powder-Free Vinyl Patient Examination Glove, Colored (Yellow) Regulation Number: 21 CFR 880,6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 1, 2010 Received: June 8, 2010
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
th for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K1000S7
INDICATIONS FOR USE
Applicant: TANGSHAN KANGYUAN GLOVE CO., LTD.
: 510(k) Number (if known): *
Device Name: Powder-free Vinyl Patient Examination Gloves, Colored (Yellow)
Indications For Use:
Powder free 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KIDODS7 510(k) Number:
§ 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.