(291 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, and does not provide therapeutic benefit.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to diagnose any condition or disease.
No
The device is a physical glove made of nitrile synthetic rubber, 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 on the examiners hand 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 diagnostic purposes.
- Device Description: The description reinforces the intended use as a barrier device made of nitrile rubber.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on the physical properties and barrier function of the gloves (tensile strength, barrier strength, irritation, sensitization, permeation), which are relevant to their intended use as a protective barrier, not for diagnostic testing.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examination Gloves are Class I disposable device which are made up of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and which meets all of the requirements of ASTM standard D6319 00a (2005).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand 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 device underwent nonclinical tests including:
a. Dermal Sensitization Test - Passes
b. Primary Skin irritation - Passes
c. Permeation testing per ASTM D 6978-05 - Passes
d. Iodine Test - Passes
e. Tensile strength - Gloves meets the requirements of ASTM D63 19-00a.
f. Barrier strength - Gloves meets the requirements of ASTM D63 19-00a.
All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5.
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
CHIENMAX VIETNAM CO.,LTD
Image /page/0/Picture/1 description: The image shows a logo for Maslac. The logo features a stylized hand with three fingers and a thumb forming a circular shape. Below the hand is the word "Maslac" in a bold, sans-serif font. The "R" in a circle indicates that the logo is a registered trademark.
KM 8, PHAM VAN DONG ROAD, HAI THANHDOUNG KINH DISTRICT HAI PHONG, HAI PHONG, TAHNH PHO, 18671, VIETNAM
OCT - 3 2011
TEL:84-313632888 FAX: 84-31336288
EXHIBIT #3
510(k) Summary
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date: August 25, 2011
1. Applicant:
Chienmax Vietnam Co. Ltd Km 8, Pham Van Dong Road, Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam
2. Manufacturer: Chienmax Vietnam Co. Ltd Km 8, Pham Van Dong Road,
Hai Thanhdoung Kinh Districthai Phong, Hai Phong, Tahnh Pho, 18671, Vietnam
3. Submitter:
Mr. Jigar Shah Official Correspondent for Chienmax Vietnam Co. Ltd
4. Address:
mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 Jigar@mdiconsultants.com
-
- Trade/proprietary Name: Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Patient Examination Gloves.
- Common Names: 6. POWDER-FREE Patient Examination Glove
-
- Classification name: Device Class I, Patient examination glove (21 CFR 880.6250, product code LZA)
8. Predicate Devices:
- Sunmax Vietnam Co. Ltd Powder free Nitrile Patient Examination Gloves. . (K101870)
1
- ULTRAWIN SDN BHD Non-Sterile Powder Free Nitrile Examination Gloves (K . 090828)
- PT. MAHAKARYA INTI BUANA Powder Free Black Nitrile Examination gloves. . (K090464)
9. Device Description:
Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examination Gloves are Class I disposable device which are made up of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and which meets all of the requirements of ASTM standard D6319 00a (2005).
10. Intended Use:
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
11. Substantial Equivalence Discussion:
A powder free patient examination glove is substantially equivalent to the predicate devices.
| Characteristic
and parameters | Chienmax
Vietnam Co.,
LTD Powder
Free Blue Nitrile
Examination
Glove
(New Device) | Sunmax Vietnam
Co. Ltd Powder
free Nitrile Patient
Examination
Gloves. (K101870) | ULTRAWIN
SDN BHD
Non-Sterile
Powder Free
Nitrile
Examination
Gloves
(K 090828) | PT.
MAHAKARY
A INTI
BUANA
Powder Free
Black Nitrile
Examination
gloves.
(K090464) | SE
Comparison |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | LZA | LZA | LZA | LZA | |
| Intended Use | A patient
examination
gloves is a
disposable device
intended for
medical purpose
that is worn
on the examiner's
hand or fingers to
prevent
contamination
between patient
and examiner. | A patient
examination gloves
is a disposable
device intended for
medical purpose
that is worn
on the examiner's
hand or fingers to
prevent
contamination
between patient and
examiner. | A patient
examination
gloves is a
disposable device
intended for
medical purpose
that is worn on
the examiner's
hand or fingers to
prevent
contamination
between patient
and examiner. | A powder-free
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. | SE |
| Width (size
medium) | 95 | 89 | 93-98 | 97.7 | Minor
Difference |
2
2
| verall length | 244 | 240 | 240 | 240.9 | Minor
Difference |
|-----------------------------------------|-----------|-----------|-----------|---------|---------------------|
| Palm thickness | 0.113 | 0.12 | Min 0.08 | 0.109 | Minor
Difference |
| Finger thickness | 0.138 | 0.12 | Min 0.08 | 0.148 | Minor
Difference |
| Tensile strength
pre aging min | 16.78 | 22 | 15 - 21 | 18.8 | Minor
Difference |
| Tensile strength
after aging min | 17.40 | 23.6 | 14-22 | 21.3 | Minor
Difference |
| Ultimate
elongation pre
aging min | 510 | 500 | 550 - 630 | 679.4 | Minor
Difference |
| Ultimate
elongation after
aging | 555 | 500 | 520 - 610 | 767.4 | Minor
Difference |
| Meets
Biocompatibility | yes | Yes | Yes | Yes | SE |
| Duration of bio-
compatibility | Limited | Limited | Limited | Limited | SE |
| Skin irritation test | Passes | Passes | Passes | Passes | SE |
| Dermal
ensitization | Passes | Passes | Passes | Passes | SE |
| Residual powder
test | Passes | Passes | Passes | Passes | SE |
| Labeling | Identical | Identical | NA | NA | Minor
Difference |
12. Summary of Testing:
| Test | Results | |
|---|---|---|
| a. | Dermal Sensitization Test | Passes |
| b. | Primary Skin irritation | Passes |
| c. | Permeation testing per ASTM D 6978-05 | Passes |
| d. | Iodine Test | Passes |
| e. | Tensile strength | Gloves meets the requirements of |
| ASTM D63 19-00a. | ||
| f. | Barrier strength | Gloves meets the requirements of |
| ASTM D63 19-00a. |
The standards used by Chienmax Vietnam Co. Ltd to determine substantial equivalence are based on ASTM D 631900a-2005. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5
There are no special labeling claims and we do not claim our gloves to be hypoallergenic.
3
13. Conclusion:
Based on the nonclinical tests performed the Chienmax Vietnam Co. Ltd Powder-free Blue Nitrile Examination Glove is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and a wavy line representing the body.
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Chienmax Vietnam Company, Limited C/O Mr. Jigar Shah Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
OCT - 3 2011
Re: K103675
Trade/Device Name: Chienmax Vietnam Company, Limited Powder Free Blue Nitrile Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 20, 2011 Received: September 22, 2011
Dear Mr. Shah:
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 enners. 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: CDRF; does not evaluate information related to contract liability warranties. We remind you, fovever, 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 89%. In this addition, FDA may publish further announcements concerning your device in the Fight first Register.
5
Page 2 - Mr. Shah
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 offelire number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Cintron
Anthony D. Weiner, P.C. 160 Broadway
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 ·
6
Attachment 1
EXHIBIT #1
Indications for Use
510(k) Number (if known): K103675
Applicant: Chienmax Vietnam Co. Ltd
Device Name: Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examination Gloves.
Indications for Use:
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
Shula R. Murphy, MD, John F. Chrocien-Williams
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K:103675