(70 days)
Not Found
No
The device is a standard patient examination glove and the summary describes only physical and material testing, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, and is not designed to treat a medical condition.
No
This device is a patient examination glove, used to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a physical patient examination glove, which is a hardware device, not software.
No, 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 examiner's hand 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 in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: It's classified as a Class I device under 21 CFR 880.6250, which is for "Patient Examination Glove." This classification is for general hospital and personal use devices, not IVDs.
- Lack of IVD Characteristics: The description and testing information do not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic or monitoring information based on specimen analysis
The device's function is purely as a physical barrier for infection control during patient contact.
N/A
Intended Use / Indications for Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D5250-06e1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Hongze Plastic Technology Co., Ltd.'s glove production are based on ASTM D5250-06e1. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level 1, 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.
A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection 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
JUL - 1 2010
EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(K) number is: _ K | 0 | 1 35
- l. Owner's Identification:
Mr. Jack Wang Hongze Plastic Technology Co., Ltd. West District of Shenze Industrial Zone, Fuqian West Road, Shenze County, Shijiazhuang, Hebei, China, 050000
2. Name of the Device:
Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
3. Predicate Device Information:
Better Care Plastic Products Co., Ltd Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) (K092301).
4. Device Description:
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D5250-06e1.
5. Intended Use:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Comparison to Predicate Devices:
Hongze Plastic Technology Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) is substantially equivalent in safety and effectiveness to the Better Care Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink).
1
EXHIBIT #1 Page 2 of 2
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Hongze Plastic Technology Co., Ltd.'s glove production are based on ASTM D5250-06e1. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level 1, 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.
A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
10. Conclusions:
Hongze Plastic Technology Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) conform fully to ASTM D5250-06e1 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. The device herein mentioned is as safe, as effective, and performs as well as or better than the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles three abstract human figures or lines, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hongze Plastic Technology Company, Limited C/O Ms. Kathy Liu Treeline Trading Incorporated 1930 Brea Canyon Road Diamond Bar, California 91765
Re: K101135
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) Regulation Number: 21 CFR 880.6250
JUL -1 2010
Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 22, 2010 Received: April 22, 2010
Dear Ms. 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.
3
Page 2- Ms. 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.
Susan Evans
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
Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
Hongze Plastic Technology Co., Ltd. Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink)
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _上(0l)35
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter-Use __ 4 (21CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
AND/ OR
Concurrent of CDRH, Office of Device Evaluation (ODE)