(310 days)
Not Found
No
The device is a simple examination glove and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device, a Powder Free Nitrile Examination Glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device is a nitrile examination glove intended to prevent contamination, not to diagnose any condition. Its performance studies and key metrics relate to its physical properties and safety for use as a barrier, not diagnostic capability.
No
The device is a physical examination glove, not a software application. The description details material properties and physical performance tests, not software functionalities.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description focuses on the physical properties and standards met by the glove, not on any diagnostic function.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
The device is a medical glove, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Gloves, Black 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 codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed device is a Powder Free Nitrile Examination Glove. The glove is available in one color: Black. The proposed device is non-sterile. The Powder Free Nitrile Examination Gloves, Black meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
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)
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in Section 6.0 and meets the following standards:
ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dimensions: Meets ASTM D6319-10 Standard requirements. Minimal value for Length: 240 mm. Minimal value for Width: 95mm.
Physical Properties: Meets ASTM D6319-10 Standard requirements. Tensile Strength Before Aging: Minimal Value: 19.05 MPa. After Accelerated Aging: Minimal Value: 16.25 MPa. Ultimate Elongation Before Aging Minimal Value: 755%. After Aging Minimal Value: 625%.
Thickness: Meets standard requirements. Palm - min. 0.09mm. Finger - min. 0.11mm.
Biocompatibility: Under the condition of the Study – Not an irritant, Not a sensitizer.
Freedom from Pinholes: Meets 21 CFR 800.20 and ASTM D5151-06 Standard Requirements. Passes AQL 2.5.
Powder Residual: Meets ASTM D6124-06 Standard requirements. Minimal Value: 0.45 mg.
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a design above them that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Pt. Maja Agung Latexindo % Emmy Tjoeng Marketing Director Shamrock Manufacturing Co. Inc. 5445 Daniels Street Chino. California 91710
Re: K161099
Trade/Device Name: Powder Free Nitrile Examination Gloves, Black Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: January 17, 2017 Received: January 19, 2017
Dear Emmy Tjoeng:
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.
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 and Part 809); 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
1
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 and Part 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K161099
Device Name
Powder Free Nitrile Examination Gloves, Black
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves, Black 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo consists of a red square with a stylized white "M" inside, followed by the company name in green, bold letters. Below the company name is the text "Manufacturer of Latex Gloves" in a smaller, black font.
Image /page/3/Picture/1 description: The image contains four certification logos. The first logo is the TUV CERT EN ISO 9001 certification mark. The second logo is the TUV NORD ISO 9001:2008 certification mark. The third logo is the TUV NORD ISO 13485:2007 certification mark with the certificate number 44 221 06 336658-001. The fourth logo is the CE marking with the number 0044, indicating compliance with the Medical Device Directive 93/42/EEC Annex V, and the certificate number 44 235 06 336658-001.
"510 (K)" SUMMARY K161099
| 1.0 Submitter | |
|---|---|
| Name of applicant | : Prakash |
| Address | : PT. MAJA AGUNG LATEXINDO |
| Jl. Utama No. 98, Pujimulyo, Sunggal 20352 | |
| North Sumatera - Indonesia | |
| Phone No. | : 62-61-8459170 |
| Fax No. | : 62-61-8459180 |
| Contact person in U.S.A | : Emmy Tjoeng | |
|---|---|---|
| Fax No. | : 909-591-8878 | |
| : emmyt@smcgloves.com |
2.0 Name of the Device
| Powder Free Nitrile Examination Gloves, Black |
|---|
| Common Name : Nitrile Exam Gloves |
| Classification Name : Patient Examination Gloves (21 CFR 880.6250) |
| Product Code : LZA |
| Date Prepared : February 23, 2017 |
3.0 Identification of The Legally Marketed Devices That equivalency is claimed:
Primary Predicate:
Chlorinated Powder Free Nitrile Examination Gloves (Black Color) Company: Worldmed Manufacturing Sdn.Bhd 510(k): K123116 Regulatory Class I Product Code: LZA.
4.0 Description of the Device:
The proposed device is a Powder Free Nitrile Examination Glove. The glove is available in one color: Black. The proposed device is non-sterile. The Powder Free Nitrile Examination Gloves, Black meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
41
Factory :
Jl. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang, Sumatera Utara - Indonesia, Phone +62-61 - 8459170 (Hunting) Fax: +62-61 - 8459180 E-mail : mal2510@indosat.net.id
4
Image /page/4/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized red and blue graphic on the left, with the company name in green text to the right. Below the company name, the text "Manufacturer of Latex Gloves" is written in a smaller, black font.
Image /page/4/Picture/1 description: The image shows four different certification logos. The first logo is the TUV CERT EN ISO 9001 certification. The second logo is the TUV NORD ISO 9001:2008 certification. The third logo is the TUV NORD ISO 13485:2007 certification with the certificate number 44 221 06 336658-001. The fourth logo is the CE Medical Device Directive 93/42/EEC Annex V certification with the number 0044 and certificate number 44 235 06 336658-001.
5.0 Indications for Use:
The Powder Free Nitrile Examination Gloves, Black 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.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves, Black are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with nitrile and meets ASTM D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D6319-10: | |
| Length ">–min. 230mm | ||
| Width ">–min. 95 ± 10mm | Meets ASTM D6319-10 | |
| Standard requirements | ||
| Minimal value for Length: | ||
| 240 mm | ||
| Minimal value for Width: 95mm | ||
| Physical Properties | ASTM D6319-10: | |
| Tensile Strength: | ||
| Before Aging: 14 MPa | ||
| After Aging: 14 MPA | ||
| Ultimate Elongation: | ||
| Before Aging: min. 500% | ||
| After Aging: min. 400% | Meets ASTM D6319-10 | |
| Standard requirements | ||
| Tensile Strength: | ||
| Before Aging: Minimal Value: | ||
| 19.05 MPa | ||
| After Accelerated Aging: | ||
| Minimal Value: 16.25 MPa | ||
| Ultimate Elongation: | ||
| Before Aging Minimal Value: | ||
| 755% | ||
| After Aging Minimal Value: | ||
| 625% | ||
| Thickness | ASTM D6319-10 | |
| Palm ">– min 0.05mm | ||
| Finger ">– min 0.05mm | Meets standard requirements | |
| Standard requirements | ||
| Palm ">– min. 0.09mm | ||
| Finger ">– min. 0.11mm |
5
Image /page/5/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO. The logo consists of two parts: a red abstract graphic on the left and the company name in green on the right. The company name is written in a bold, sans-serif font, with "PT. MAJA AGUNG" on the top line and "LATEXINDO" on the bottom line.
Image /page/5/Picture/1 description: The image shows four different certification logos. The first logo is a TUV CERT EN ISO 9001 certification. The second logo is an ISO 9001:2008 TUV NORD certification. The third logo is an ISO 13485:2007 TUV NORD certification with the certificate number 44 221 06 336658-001. The fourth logo is a CE 0044 Medical Device Directive 93/42/EEC Annex V certification with the certificate number 44 235 06 336658-001.
Manufacturer of Latex Gloves
| Biocompatibility | ISO 10993-10:2010
Biological evaluation of
medical devices - Part 10:
Tests for irritation and skin sensitization | Under the condition of the Study –
Not an irritant |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| | ISO 10993-10:2010
Biological evaluation of medical
devices -Part 10:
Tests for irritation and skin sensitization | Under the condition of the
Study -Not a sensitizer |
| Freedom from
Pinholes | 21 CFR 800.20; ASTM D5151-06
AQL 2.5 | Meets 21 CFR 800.20 and ASTM
D5151 -06 Standard
Requirements
Passes AQL 2.5 |
| Powder
Residual | ASTM D6124-06:
$\leq$ 2 mg/ glove | Meets ASTM D6124-06
Standard requirements
Minimal Value: 0.45 mg |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in Section 6.0 above and meets the following standards:
ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
43
Factory :
Jl. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang, Sumatera Utara - Indonesia, Phone +62-61 - 8459170 (Hunting) Fax: +62-61 - 8459180 E-mail : mal2510@indosat.net.id
6
Image /page/6/Picture/0 description: The image contains the logo for PT. MAJA AGUNG LATEXINDO. The logo consists of a stylized red graphic on the left, followed by the company name in green, block letters. The words "PT. MAJA AGUNG" are on the top line, and "LATEXINDO" is on the bottom line.
Image /page/6/Picture/1 description: The image shows four different certification logos. The first logo is the TUV CERT EN ISO 9001 certification. The second logo is the TUV NORD ISO 9001:2008 certification. The third logo is the TUV NORD ISO 13485:2007 certification with the certificate number 44 221 06 336658-001. The fourth logo is the CE 0044 Medical Device Directive 93/42/EEC Annex V certification with the certificate number 44 235 06 336658-001.
Manufacturer of Latex Gloves
8.0 Substantial Equivalence Comparison of K161099
The Powder Free Nitrile Examination Gloves, Black is substantially equivalent to the predicate device with respect to intended use, product features and the technological characteristics. The substantial equivalence comparison is presented in the table below:
| Characteristic
and
Parameters | Chlorinated Powder Free
Nitrile Examination Gloves
(Black Color)
Bhd. K123116
(Predicate) | Powder Free Nitrile
Examination Gloves,
Black. K161099
(Proposed) | Substantial
Equivalence
(SE) |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LZA | LZA | SAME |
| Intended use | Intended for medical purposes
that is worn on the examiner's
hands or fingers to prevent
contamination between
patient and examiner. | Intended for medical
purposes that is worn on
the examiner's hand or
finger to prevent
contamination between
patient and examiner. | SAME |
| Indications for
Use Statement | The Chlorinated Powder Free
Nitrile Examination Gloves
(Black Color) is a single use
disposable device intended for
medical purposes that is worn
on the hand of healthcare and
similar personnel to prevent
contamination between
healthcare personnel and the
patient | The Powder Free Nitrile
Examination
Gloves,
Black 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. | SAME |
| Device Material | Nitrile Synthetic Latex | Nitrile Synthetic Latex | SAME |
| Color | Black | Black | SAME |
| Additives | No flavor additive | No flavor additive | SAME |
| Instruction for
Use on Labeling | Single Use Only | Single Use Only | SAME |
| Construction | Ambidextrous | Ambidextrous | SAME |
| Sterility | Non-sterile | Non-sterile | SAME |
| Acceptance
Criteria | ASTM D6319-10 | ASTM D6319-10 | SAME |
| Dimensions | Meets ASTM D 6319-10 | Meets ASTM D 6319-10 | SAME |
| | Thickness at Finger - min.
0.05mm
Thickness at Palm - min.
0.05mm | Overall Length – min.
230mm
Width(±5mm)
Size XS - 75mm
Size S - 85mm
Size M - 95mm
Size L - 110mm
Size XL - 115mm
Thickness at Finger - min.
0.05mm
Thickness at Palm - min.
0.05mm | |
| | Physical
Properties | Meets ASTM D6319-10:
Before Aging
Tensile strength -min.
14.0MPa
Ultimate Elongation -min.
500%
After Aging
Tensile Strength – min
14.0MPa
Ultimate Elongation -min.
400% | |
| Biocompatibility
Test
a. Irritation Tests
b. Skin
Sensitization
Tests | Under the conditions of
the study, the subject
device is a non-irritant and
non-sensitizer.
(ISO 10993-10 (2010)) | Under the conditions of
the study, the subject
device is a non-irritant
and non-sensitizer.
(ISO 10993-10 (2010)) | SAME |
| Residual Powder Test | Meets ASTM D6124-06:
≤ 2 mg/ glove | Meets ASTM D6124-06:
≤ 2 mg/ glove | SAME |
| Freedom from Holes | Meets ASTM D5151-06
AQL 2.5 | Meets ASTM D5151-06
Passes AQL 2.5 | SAME |
44
Factory :
Jl. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang, Sumatera Utara - Indonesia, Phone +62-61 - 8459170 (Hunting) Fax: +62-61 - 8459180 E-mail : mal2510@indosat.net.id
7
Image /page/7/Picture/0 description: The image contains the logo for PT. MAJA AGUNG LATEXINDO. The logo consists of two parts: a stylized red graphic on the left and the company name in green on the right. The company name is written in two lines, with "PT. MAJA AGUNG" on the top and "LATEXINDO" on the bottom.
Image /page/7/Picture/1 description: The image shows four certification logos. The first logo is the TUV CERT EN ISO 9001 certification. The second and third logos are TUV NORD ISO 9001:2008 and ISO 13485:2007 certifications with certificate numbers 44 221 06 336658-001. The fourth logo is the CE 0044 Medical Device Directive 93/42/EEC Annex V certification with certificate number 44 235 06 336658-001.
Manufacturer of Latex Gloves
Factory : II. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang, Sumatera Utara - Indonesia, Phone +62-61 - 8459170 (Hunting) Fax: +62-61 - 8459180 E-mail : mal2510@indosat.net.id
8
Image /page/8/Picture/0 description: The image shows the logo for PT. MAJA AGUNG LATEXINDO, a manufacturer of latex gloves. The logo features a stylized red graphic on the left, followed by the company name in green text. Below the company name is the text "Manufacturer of Latex Gloves".
Image /page/8/Picture/1 description: The image contains four certification logos. The first logo is a TUV CERT EN ISO 9001 certification mark. The second logo is an ISO 9001:2008 certification mark with TUV NORD. The third logo is an ISO 13485:2007 certification mark with TUV NORD and the certificate number 44 221 06 336658-001. The fourth logo is a CE mark with the number 0044, indicating compliance with the Medical Device Directive 93/42/EEC Annex V, and the certificate number 44 235 06 336658-001.
9.0 Conclusion
The Powder Free Nitrile Examination Gloves, Black meet all of the requirements of FDA-recognized consensus standards; ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10:2010 and meet our labeling claims and pinhole acceptable quality level (AQL) as shown above.
There are no significant differences between the subject and predicate devices and the two are similar in terms of intended use, materials, and performance.
The conclusion drawn from the nonclinical tests demonstrate that the device is as safe and as effective and performs as well as the legally marketed device.
Factory : Jl. Utama No. 98 Pujimulyo, Sunggal 20352 Deli Serdang, Sumatera Utara - Indonesia, Phone +62-61 - 8459170 (Hunting) Fax: +62-61 - 8459180 E-mail : mal2510@indosat.net.id