(112 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML technology.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
This device is an examination glove, intended to prevent contamination and for use with chemotherapy drugs. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made from nitrile latex compound, which is a hardware component.
Based on the provided text, 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 of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs". This describes a barrier device used externally on the examiner.
- Device Description: The description reinforces this, identifying it as a "patient examination glove made from nitrile latex compound".
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. The testing mentioned (biocompatibility and chemotherapy drug permeability) relates to the glove's performance as a barrier and its safety for the user, not to diagnosing or monitoring a patient's condition through analysis of a sample.
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, powder free, with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Blue 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
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)
Performance was evaluated based on physical properties and resistance against chemotherapy drugs.
Key results included:
- Tensile Strength (MPa) before and after aging: 14min
- Ultimate Elongation (%) before aging: 500min, after aging: 400min
- Pin-hole Level: AQL 2.5, Inspection Level G-1
- Biocompatibility: non-irritant and non-sensitizer
- Breakthrough detection time for various chemotherapy drugs, with Carmustine (BCNU) (3.3mg/ml) at 1.3 minutes and Thiotepa (10mg/ml) at 67.8 minutes, while most other drugs showed > 240 minutes.
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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7,2014
Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23836, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Kamunting Perak, Malaysia 34600
Re: K141623
Trade/Device Name: EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs Labeling Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 5, 2014 Received: September 5, 2014
Dear Mr. Suresh 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
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,
Susan Runno DDS, MA
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) K141623
Device Name
EMG Blue Nitrile Examination Gloves Powder Free with Chemotherapy Drues
Indications for Use (Describe)
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs
| Chemotherapy Drug and concentration | Minimum Breakthrough detection time in Minutes, 0.01µg/cm²/minute |
|---|---|
| 1)Carmustine (BCNU) (3.3mg/ml) | 1.3 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (100mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 67.8 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time : Carmustine (BCNU) (3.3mg/ml)
Thiotepa (10mg/ml)
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)
3
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4
formerly known as Sinetimed Consumables Sdn. Bhd.
23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. +60-5-891 2777 FAX +60-5-891 2999
Appendix 2 (510k#: K141623)
510(K) Summary EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
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 : 23rd September 2014
3.0 Name of the Device
Trade Name / Proprietary Name : EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs.
Device Name : Nitrile Patient Examination gloves.
Device Classification Name : Patient Examination gloves (21 CFR 880.6250).
Device Class : Class I.
Product Code : Nitrile-LZA and LZC.
5
nerly known as Sinetimed Consumables Sdn. Bhd.
t 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777
Appendix 2 (510k#: K141623)
4.0) Identification of The Legally Marketed Device :
Class I patient Examination glove with tested for use with Chemotherapy Drugs, Powder Free,LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K110921, Cornflower Powder Free Exam glove tested for use with Chemotherapy Drugs (Non sterile) .
Device Description 5.0
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, powder free, with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Blue 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
6.0 Specification for Nitrile gloves: 6.1 Dimension and Thickness of Gloves
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) | 270min | 270min | 270min | 270min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
| Thickness at Finger Tip (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
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#: K141623)
6.1.2 Gloves Physical Properties and Holes
| 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 |
Gloves meet all the specification listed in ASTM D 6319-10
| Characteristics | Acceptance Criteria | EMG Blue Nitrile
Medical Examination
Gloves Powder Free
with tested for use with
chemotherapy drugs
(K141623) | Nitrile Cornflower Blue
Powder Free gloves tested
for use with
Chemotherapy drugs
(Non-Sterile ), K110921 |
|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZC | LZC | LZC |
| 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. |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound |
| Colour | Blue | Blue | Blue |
| Sterility | Non sterile | Non sterile | Non sterile |
| Single used | Single used | Single used | Single used |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile
Section 2A-3 |
| | Appendix 2
(510k#: K141623) | | |
| Dimensions | Overall Length (mm)
Min 270mm
Width (± 5mm)
Size S = 85mm
Size M = 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm (mm)
Min; 0.10mm
Thickness at Finger Tip (mm)
Min 0.10 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical properties | Before Ageing
Tensile Strength (MPa)
= 14min
Ultimate Elongation (%)
= 500min
After Aging at 70°C for
168 hrs @ 100°C for 22 hrs
Tensile Strength (MPa)
= 14min
Ultimate Elongation (%)
= 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from pinholes | AQL 2.5
Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biological Evaluation on
Medical Device -
-Primary Skin Irritation
Test | | 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 | | 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. |
| Resistance against
Chemotherapy Drugs | | 1) Carmustine (3.3mg/ml
or 3000ppm),
Breakthrough : 1.3 min. | 1) Carmustine (3.3mg/ml
or 3000ppm),
Breakthrough : 4.5min.
Section 2A-4 |
| | | Appendix 2
(510k#: K141623) | |
| Standards Practice for
Assessment of resistance of
Medical Glove to Permeation
by Chemotherapy drugs
ASTM D6978-05(2013) | 2) Cyclophosphamide
(20mg/ml or
20,000ppm),
Breakthrough time :
240 min. | 2) Cyclophosphamide
(20mg/ml or 20,000ppm),
Breakthrough time : >240
min.
- Cytarabine (100mg/ml
or 100,000ppm),
Breakthrough time : >240
min. | |
| | 3) Cytarabine (100mg/ml
or 100,000ppm),
Breakthrough time :
240 min. | 4)Doxorubicin
Hydrochloride (2.0mg/ml
or 2000ppm),
Breakthrough time : >240
min. | |
| | 4)Doxorubicin
Hydrochloride (2.0mg/ml
or 2000ppm),
Breakthrough time :
240 min. | 5) Etoposide (20mg/ml or
20,000ppm), Breakthrough
time : >240 min. | |
| | 5) Etoposide (20mg/ml
or 20,000ppm),
Breakthrough time :
240 min. | 6) Flourouracil (50mg/ml
or 50,000), Breakthrough
time : >240 min. | |
| | 6) Flourouracil (50mg/ml
or 50,000), Breakthrough
time : >240 min. | 7) Methorexate (25mg/ml
or 25,000ppm),
Breakthrough time : > 240
min. | |
| | 7) Methorexate (25mg/ml
or 25,000ppm),
Breakthrough time : >
240 min. | 8) Paclitaxel (6mg/ml or
6,000ppm), Breakthrough
time : >240 min. | |
| | 8) Paclitaxel (6mg/ml or
6,000ppm),
Breakthrough time :
240 min. | 9) Thiotepa (10mg/ml or
10,000ppm), Breakthrough
time : 6.88 min. | |
| | 9) Thiotepa (10mg/ml or
10,000ppm),
Breakthrough time : 67.8
min. | | |
7
ECO Medi Glove Sdn. Bhd. (815262-D)
(formerly known as Sinetimed Consumables Sdn. Bhd.)
(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
8
(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
9
(formerly known as Sinetimed Consumables Sdn. Bhd.)
23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. +60-5-891 2777
Appendix 2 (510k#: K141623)
7.0 Intended use of the Device
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 and for use with chemotherapy drugs . It is for overthe-counter use.
In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
| Chemotherapy Drug and concentration | Minimum Breakthrough detection time
in Minutes,0.01µg/cm²/minute |
|---------------------------------------|---------------------------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml) | 1.3 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cytarabine (100mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 67.8 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time.
Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)
10
(formerly known as Sinetimed Consumables Sdn. Bhd.)
23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. I +60-5-891 2777
Appendix 2 (510k#: K141623)
8.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion
There are no differences in technological characteristics of the subject device compare with the predicate device.
The gloves are made from nitrile latex compound, Blue colour, Powder free and nonsterile. The gloves met all the specifications in ASTM D6319-10 Standard specification for Nitrile Examination Gloves as well Biological Evaluation on medical device. Additionally, the gloves have been tested for permeability to chemotherapy drugs.
Based on the intended uses, physical properties and technological characteristics, the subject device is as safe and effective as a legally marketed device- K110921, Nitrile Cornflower Blue Powder Free Exam Gloves Medical Exam tested for use with Chemotherapy Drugs test, and its does not raise different questions of safety and effectiveness.
9.0 Conclusion
Based on intended uses, technological characteristics and non - clinical performance data, the EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs (K141623) is substantially equivalent to the predicate device (K110921).