(68 days)
Powdered 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 Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported 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 Amount | ASTM standard D 5250-06 e1 and D6124-06 | Meets (<10mg/dm2) |
| Biocompatibility | Primary Skin Irritation in rabbits (AAMI / ANSI / ISO 10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (AAMI / ANSI / ISO 10993-10) | 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 when reporting the device performance (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility).
The data provenance is not explicitly stated as retrospective or prospective, nor are specific countries of origin for the data provided. However, the tests are performed against international and US standards (ASTM, 21 CFR, ISO).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The standards themselves define the test methodologies, but who performed the tests or how many experts validated the "ground truth" (e.g., interpreting if a skin irritation occurred) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1). The tests are performed according to established standards, where the pass/fail criteria are typically objective and defined by the standard itself.
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 typically associated with AI/CAD devices where human readers' performance is compared with and without AI assistance to measure improvement. The device in question is a medical glove, for which such a study would not be applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance evaluation was not done. This concept is relevant for AI/software algorithms. The device is a physical product (medical gloves), and its performance is evaluated through material and biological conformity tests against established standards.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on objective measurements and observations performed according to recognized industry standards and regulatory requirements. For example:
- Physical dimensions are measured.
- Physical properties (e.g., tensile strength, elongation) are measured.
- Freedom from pinholes is determined by a water leak test.
- Powder amount is measured.
- Biocompatibility (skin irritation and sensitization) is determined by in-vivo animal studies with specific observational endpoints defined by the ISO standard.
Essentially, the ground truth is established by strict adherence to the methodologies outlined in the referenced standards (ASTM D 5250-06 e1, 21 CFR 800.20, ASTM D6124-06, AAMI / ANSI / ISO 10993-10).
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm, and therefore, the concept of a "training set" is not applicable. The performance is based on manufacturing and material testing, not machine learning.
9. How the Ground Truth for the Training Set was Established
As stated above, this device is not an AI/ML algorithm, so there is no training set or ground truth established for one.
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Section C 510(k) Summary (21 CFR 807.92)
510(k) Summary
DEC 1 3 2010
"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: K1029 1(a " (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 :
Submitter's address :
Heze Juxinyuan Food Co., Ltd.
Jinzhuang Zone, Suji, Caoxian , Heze City, Shandong Submitter's address : Province, 274415,China 0086-530-5022111 Phone number : Fax number 0086-530-5311988 : Name of contact person: Mr. Wenzhong Zhang Date the summary was prepared: Sep.19, 2010
[(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, Clear (non-colored) Proprietary/Trade name: Powdered Vinyl Patient Examination Gloves. Clear (non-colored) Other clients private labeling Common Name: Exam gloves 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, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Section C
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Powdered Vinyl Patient Examination Gloves. Predicate device: Clear(Non-colored) , ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.
[(a)(4)] A description of the device
Device Description: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powdered 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The Powdered 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 |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 eland D6124-06 | Meets<10mg/dm2 |
| Biocompatability | Primary Skin Irritation in rabbitsAAMI / ANSI / ISO 10993-10 | PassesNot a Primary Skin Irritation |
| Dermal sensitization in the guinea pigAAMI / ANSI / ISO 10993-10 | 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, Clear (non-colored), meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-87: AAMI / ANSI / ISO 10993-10:2002.
[(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, 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 Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powdered Vinyl Patient Examination Gloves, Clear(Non-colored) ,ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and appears to be a header or title. The ampersand symbol (&) is also present between the words "HEALTH" and "HUMAN".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
HEZE Juxinyuan Food Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company, Limited Room 1606 Building 1 Jian Xiang Yuan No. 209 Bei Si Huan Zhong Road Hai Di Beijing, China 100083
DEC 1 3 2010
Re: K102976
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 27, 2010 Received: October 6, 2010
Dear Mr. Chu 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.
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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 (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.
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 yours,
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
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Section B Indications for Use
DEC+1*3 2010
INDICATIONS FOR USE
Heze Juxinyuan Food Co.,Ltd. Applicant:
510(k) Number (if known): * K | O2976
Device Name: Powdered Vinyl Patient Examination Gloves, Clear (non-colored)
Indications For Use:
Powdered 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) 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)
E. Ndubuisi-Williams
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102976
§ 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.