(102 days)
Not Found
No
The device description and intended use clearly define it as a standard patient examination glove, with no mention of AI or ML capabilities. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No
Explanation: The device is a patient examination glove used to prevent contamination, not to treat a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function such as detecting, identifying, or monitoring medical conditions.
No
The device description clearly identifies the device as a physical patient examination glove, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The classification is "Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove." This classification falls under the General and Plastic Surgery Device panel, not the IVD panel.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The focus is entirely on physical protection.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Product codes
LZA
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LZA; and meets all requirement of ASTM Standard D6319-10.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The standards used for Xinwei (Shandong) Plastic and Rubber Products Co., Ltd. glove production are based on ASTM-D-6319-10. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or rensitization reactions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510 (K) SUMMARY
OCT 1 6 2012
KI21992
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
1. Submitter's Identification:
Xinwei (Shandong) Plastic and Rubber Products Co., Ltd. No. 41 Shuangshan Road Boshan District, Zibo, Shandong China
Contact Person: Liu, Frank Tel: 909-548-4828 Fax: 909-548-4807 Email: Johnzhao@basicmedical.com
Date summary prepared: Oct 1, 2012
2. Name of the Device:
Xinwei (Shandong) Plastic and Rubber Products Co., Ltd. Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue Color
3. Predicate Device Information:
Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K082598)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LZA; and meets all requirement of ASTM Standard D6319-10.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
6. Comparison to Predicate Devices:
1
Xinwei (Shandong) Plastic and Rubber Products Co., Ltd. Patient Nitrile Examination Gloves, Powder-Free, Non-Sterile, Blue color are substantially equivalent in safety and effectiveness to the Tangshan Zhonghong Pulin Group Co., Ltd. Powder -Free Nitrile Patient Examination Gloves.
7. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Xinwei (Shandong) Plastic and Rubber Products Co., Ltd. glove production are based on ASTM-D-6319-10. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or rensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "[vowder-free" claims (contain no more than 2 mg powder per glove).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Xinwei (Shandong) Plastic and Rubber Products Co., Ltd. Patient Nitrile Patient Examination Gloves, Powder-Free, Non-Sterile, Blue color, conform fully to ASTM-D-6319-10 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
2
| Description | Proposed Device | Predicate Device (K082598) |
|---|---|---|
| Xinwei (Shandong) Plastic and Rubber | ||
| Products Co., Ltd. Synthetic, Powder-Free | ||
| Nitrile Examination Gloves, Blue color | Tangshan Zhonghong Pulin Group Co., | |
| Ltd. Powder Free Nitrile Patient | ||
| Examination Gloves | ||
| Indication for Use | Disposable device intended for medical | |
| purposes that is worn on the examiner's | ||
| hand or finger to prevent contamination | ||
| between patient and examiner | Substantially equivalent | |
| Basic Design | A garment covering the hand and waist | |
| area. Clovers have separate sheaths or | ||
| openings for each finger and the thumb. | Substantially equivalent | |
| Materials Used | Nitrile Latex (NBR) | |
| Sulfur | ||
| Accelerator, ZDBC | Same | |
| Single Use | Yes | Yes |
| Size | S,M,L,XL | Information Unavailable |
| Sterile | Not sterile | Not sterile |
| Dimension | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical Property | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary Skin Irritation | ISO 10993-10 passes | ISO 10993-10 passes |
| -Dermal Sensitization | ISO 10993-10 passes | ISO 10993-10 passes |
| Tensile Strength | >14 MPa | >14 MPa |
| Ultimate elongation before | ||
| aging | >500 | >500 |
| Ultimate elongation after | ||
| aging | >500 | >500 |
.
:
:
Side-by-Side Comparison of Intended Use, Design, Material, Biocompatibility, and Performance Testing Table 7-2.
.
:
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
1 6 2012
Xinwei (Shandong) Plastic and Rubber Products Company, Limited C/O Basic Medical Industries. Incorporated Mr. Frank Liu President 12390 East End Avenue Chino. California 91710
Re: K121992
Trade/Device Name: Patient Nitrile Examination Gloves, Powder-Free, Non-Sterile, Blue Color Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 24, 2012 Received: August 28, 2012
Dear Mr. Liu:
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.
4
Page 2- Mr. Liu
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 yours,
Antion D.n.n
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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Image /page/5/Picture/0 description: The image shows a black handprint on a white background. The handprint is somewhat distorted, with thick fingers and a rough outline. The handprint appears to be a left hand, with the thumb pointing to the left. The handprint is positioned in the upper left corner of the image.
Xinwei (Shandong) Plastic and Rubber Products Co., Ltd. No. 41 Shuangshan Road, Boshan District, Zibo, Shandong, China Tel: 0086-15552664010
INDICATIONS FOR USE
Applicant: Xinwei (Shandong) Plastic and Rubber Products Co., Ltd.
510(k) Number: KI21992
Device Name: Patient Nitrile Examination Gloves, Powder free, Non-Sterile, Blue Color
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use
Over the Counter Use X
Factory Initials
Elijah T. Clarence-Webster
of Anesthesiology, General Hospital
510(k) Number: K 121992