(126 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of examination gloves, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is described as powder-free patient examination gloves, intended to prevent contamination between patient and examiner. This is a barrier device, not one that diagnoses conditions.
No
The device is a physical product (examination gloves) and does not involve any software 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 "disposable device intended for medical purpose that is worn on the examiner's 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 the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The description focuses on the material (nitrile), color, and physical characteristics of the glove. It references a standard for examination gloves (ASTM D6319-10) and a product code (LZA) associated with patient examination gloves, not IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information. The performance studies focus on the physical properties of the glove (tensile strength, elongation, pin-holes) and biological safety (skin irritation, sensitization), which are relevant to a barrier device, not an IVD.
Therefore, this device is a medical device, specifically a patient examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A Powder Free Patient examination gloves is a 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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
Black Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Black colour, powder free and non sterile.
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 / 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)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the profile design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan, Malaysia 34600
Re: K141579
Trade/Device Name: EMG Black Nitrile Medical Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 10, 2014 Received: September 12, 2014
Dear Mr. Kumar:
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.
1
Page 2 - Mr. Kumar
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141579
Device Name
EMG Black Nitrile Medical Examination Glove Powder Free
Indications for Use (Describe)
A Powder Free Patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
(formerly known as Sinetimed C nsumables Sdn. Bhd.
t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. L +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
510(K) Summary EMG Black Nitrile Medical Examination Glove Powder Free .
1.0 Submitter :
| Company Name | : ECO MEDI GLOVE SDN. BHD. |
|---|---|
| Company Address | : Lot 23826,Jalan Tembaga Kuning |
| Kamunting Raya Industrial Estate | |
| 34600,Kamunting Perak | |
| Malaysia . | |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| : suresh@ecomediglove.com.my |
- 2.0 Preparation Date : 03th October 2014 .
3.0 Name of the Device
Trade Name / Proprietary Name : EMG Black Nitrile Medical Examination Gloves Powder Free .
Device Name : Nitrile Patient Examination gloves .
Device Classification Name : Patient Examination gloves (21 CFR 880.6250).
Device Class : Class I .
Product Code : Nitrile-LZA .
Section 2A-1
4
as Sinetimed (
t 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777
APPENDIX 2 510K#:141579
4.0 Identification of The Legally Marketed Device :
Class I patient Examination gloves,Powder Free,LZA which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K112924, RS Black Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) .
5.0 Description of Device :
Black Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Black colour, powder free and non sterile.
6.0 Executive summary :
EMG Black Nitrile Medical Examination Glove Powder Free is a disposable glove made of nitrile latex compound Black colour powder free. This Black Nitrile Medical Examination Gloves Powder Free 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 .
6.1.1.1 Dimension and Thickness of Gloves .
6.1.1 Specification for Nitrile gloves:
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) | 230min | 230min | 230min | 230min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.05min | 0.05min | 0.05min | 0.05min |
| Thickness at Finger Tip (mm) | 0.05min | 0.05min | 0.05min | 0.05min |
Section 2A-2
5
(formerly known as Sinetimed Consumables Sdn. Bhd.)
t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALA YSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
| Measurement | Before Ageing | After Aging at 70 °C for
168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|---------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 |
6.3.2.2 Gloves Physical Properties and Holes
Gloves meet all the specification listed in ASTM D 6319-10.
7.0 Intended use of the Device :
A Powder-free patient examination gloves 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. It is for over-the-counter use .
8.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion
There is no different technology characteristics compared to the predicate device . Gloves are made from nitrile latex compound, Black colour, powder free and non sterile. It is equivalent to K 112924, RS Black Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) .
| Characteristics | Acceptance Criteria | EMG Black Nitrile
Medical Examination
Gloves
Powder Free, K141579 | RS Black Nitrile Medical
Examination Gloves
Powder Free
(Non-Sterile) K112924 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA | LZA |
| Intended use | 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. The device is
for over-the-counter use. | 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.
The device is for over-
the-counter use. | 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. The
device is for over-the-
counter use. |
6
(formerly known as Sinetimed Consumables Sdn. Bhd.)
Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
| Material use | Not made from Natural Rubber
Latex. | Nitrile latex compound. | Nitrile latex compound. | | Before Ageing | | |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------|---------------------|-------------------------------------------------------|---------------------|---------------------|
| Colour | Black | Black | Black | | Tensile Strength (MPa)
= Min 14min | | Meets ASTM D6319-10 |
| Sterility | Non sterile | Non sterile | Non sterile
Section 2A-3 | | Ultimate Elongation (%)
= Min 500min | | |
| Dimensions | Overall Length (mm)
= Min 230mm
Width (± 5mm)
Size S = 85mm
Size M = 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm (mm)
= Min 0.05min
Thickness at Finger Tip (mm)
= Min 0.05min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Physical properties | After Aging at 70°C for
168 hrs @ 100°C for 22 hrs | Meets ASTM D6319-10 | |
| | Tensile Strength (MPa)
= Min 14min
Ultimate Elongation (%)
= Min 400min | | | | | | |
7
ECO Medi ( (815262-D)
(formerly known as Sinetimed ( umables S
Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
| Freedom from pinholes | AQL 2.5
Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
|-----------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Residual Powder | $\leq$ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biological Evaluation on
Medical Device -
Primary Skin Irritation
Test . | Test Article was non irritant. | Under the conditions of
this study, the test article
was a non-irritant . | Under the conditions of
this study, the test article
was a non-irritant . |
| Biological Evaluation on
Medical Device-
Dermal Sensitization
Assay . | Test Article was non
sensitizer. | Under the conditions of
this study, the test article
was a non-sensitizer. | Under the conditions of
this study, the test article
was a non-sensitizer. |
9.0 Conclusion
It can be concluded that EMG Black Nitrile Medical Examination Gloves Powder Free
and predicate devices are substantially equivalent base on intended uses, physical
properties, technological characteristics and non-clinical performance .
Section 2A-5