(102 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No
The device, a patient examination glove, is intended for contamination prevention, not for treating or diagnosing a medical condition.
No
Explanation: The device described is a patient examination glove, which is intended to prevent contamination between healthcare personnel and the patient. Its function is protective, not diagnostic.
No
The device description clearly identifies the device as a physical patient examination glove made of nitrile, which is a hardware component.
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 "patient examination glove" worn on the hand to prevent contamination between healthcare personnel and the patient. This is a barrier device for infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description classifies it as a Class I device under 21 CFR 880.6250, which is the regulation for patient examination gloves. This classification is for general and plastic surgery devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on physical properties, barrier integrity (water fill test), and biocompatibility (skin irritation).
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 (comma separated list FDA assigned to the subject device)
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, 80LYZ, and meets all requirement of ASTM Standard D6319-05.
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
healthcare and similar personnel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
11102593
... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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:
Zibo Yingbo Medical Products Co., Ltd. Qilu Chemical Industry Park Zhangdian District, Zibo, Shandong, China
DEC 2 0 2010
Date summary prepared: Nov. 24, 2010
2. Name of the Device:
Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color
3. Predicate Device Informaton:
Sunmax Enterprise Shanghai Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free (K090336)
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, 80LYZ, and meets all requirement of ASTM Standard D6319-05.
Intended Use: ર્જ
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Comparison to Predicate Devices: 6.
Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder-Free, Blue Color are substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Nitrile Patient Examination Gloves and Tangshan Zhonghong Pulin Group Co., Ltd. Powder -Free Nitrile Patient Examination Gloves.
1
KI02593
7. . . . Discussion of Non-Clinical tests performed for Determination of - - - - - - - - - - - - - -Substantial Equivalence are as follows:
The standards used for Zibo Yingbo Medical Products Co., Ltd. glove production are based on ASTM-D-6319-05. 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 sensitization 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 "powder-free" claims (contain no more than 2 mg powder per glove).
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder-Free, Blue Color conform fully to ASTM-D-6319-05 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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with flowing lines representing the body and head. The figure is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zibo Yingbo Medical Products Company, Limited C/O Mr. Frank Liu President Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
Re: K102593
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: November 24, 2010 Received: November 29, 2010
FEB 22 2011
Dear Mr. Liu:
This letter corrects our substantially equivalent letter of December 20, 2010.
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 (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 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. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anthony V. as
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
4
Zibo Yingbo Medical Products Co., Ltd.
Qilu Chemical Industry Park Zhangdian District, Zibo, Shandong, China
INDICATIONS FOR USE
Applicant: Zibo Yingbo Medical Products Co., Ltd.
510(k) Number:
Patient Nitrile Examination Gloves, Powder free, Non-Sterile, Device Name: 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
Elizabeth F. Plamie-Welle
(Division Sign-Off) (Division Olgh Oly), General Hospital Infection Control, Dental Devices
510(k) Number: K102593