(72 days)
Not Found
No
The device description and intended use clearly define a standard patient examination glove, and there is no mention of AI or ML technology in any section of the summary.
No
A patient examination glove is intended to prevent contamination between patient and examiner, not to provide therapy or treatment.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic. The provided information describes its classification, materials, and performance testing related to its physical properties and safety, but makes no mention of diagnostic capabilities, measurements of health parameters, or disease detection.
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 "patient examination glove...worn upon the examiner's hands or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during patient examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is classified as a Class I device under 21 CFR 880.6250, which is for "Patient Examination Glove." This classification is for a general medical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The information provided consistently points to a physical barrier device used for infection control during patient examinations, which falls outside the scope of In Vitro Diagnostics.
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 D6319-05.
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
examiner / medical purposes
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 Shandong Junchi Medical 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 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).
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
KIBIEST
510 (K) SUMMARY
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:
Shandong Junchi Medical Products Co., Ltd. No.9, Yaowang Road Wangfu Industry Park Qingzhou, Shandong, China
Date summary prepared: May 18, 2012
2. Name of the Device:
Shandong Junchi Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color
3. Predicate Device Information:
Tangshan Zhonghong Pulin Group Co., Ltd Powder -Free Nitrile Patient Examination Gloves (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 D6319-05.
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:
Shandong Junchi Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder-Free, blue color are substantially equivalent in safety and effectiveness Tangshan Zhonghong Pulin Group Co., Ltd. Powder -Free Nitrile Patient Examination Gloves.
AUG 3 2012
1
7. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Shandong Junchi Medical 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 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:
Shandong Junchi Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder-Free, 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.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Shandong Junchi Medical Products Company, Limited C/O Ms. Cecily Sheng Official Correspondent Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
3 2012 AUG
Re: K121526
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: July 6, 2012 Received: July 10, 2012
Dear Ms. Sheng:
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 - Ms. Sheng
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
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Image /page/4/Picture/0 description: The image shows a black and white graphic of a hand holding a globe. The hand is stylized with thick fingers and a textured surface. The globe is positioned in the palm of the hand and shows the continents. The image is simple and symbolic, suggesting concepts like global care or environmental protection.
Shandong Junchi Medical Products Co., Ltd.
No.9, Yaowang Road Wangfu Industry Park Qingzhou, Shandong, China Tel: 0086-13355336549
INDICATIONS FOR USE
Shandong Junchi Medical Products Co., Ltd. Applicant:
510(k) Number: Kוגובגוגון
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
Manu Sont
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K121526 ን10(k) Number: _