(143 days)
Not Found
No
The device description and performance studies focus on the physical properties and material standards of examination gloves, with no mention of AI or ML.
No
The device is described as a glove intended to prevent contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device is a glove, intended for preventing contamination, not for diagnosing any condition or disease. Its purpose is protective, not diagnostic.
No
The device described is a physical medical device (examination gloves) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hands or finger to prevent contamination patient and examiner." This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the material and manufacturing standards for examination gloves, not on any components or processes used for testing samples from the human body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the gloves (meeting ASTM and ISO standards), not on diagnostic accuracy or performance.
In summary, these gloves are intended for physical protection and contamination prevention, which is a different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The Glovanil™ Blue Nitrile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY, LZA
Device Description
Glovatex™ White Latex Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are in white color, non-sterile and powder free.
Glovanil™ Blue Nitrile Gloves are manufactured to meet all the current specifications listed under the ASTM Specification ASTM D6319 - 19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile compound. These gloves are in Blue color, non-sterile and powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands 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)
Summary of Non-Clinical Testing
The Glovatex™ White Latex Gloves meet the requirements of ASTM D3578 - 19, ASTM D 6124-06(2017), ISO10993-5:2009(E), ISO 10993-10:2010(E), ISO 10993-11:2017(E), USP 41 and ASTM D 5151-19.
The Glovanil™ Blue Nitrile Gloves meet the requirements of ASTM D 6319-19, ASTM D 6124-06(2017), ISO10993-5:2009(E), ISO 10993-10:2010(E), ISO 10993-11:2017(E), USP 41 and ASTM D 5151-19.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the Glovatex™ White Latex Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192329.
The conclusion drawn from the nonclinical tests demonstrates that the GlovaniI™ Blue Nitrile Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K200326.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 24, 2022
Avecena Gloves Sdn Bhd % Mehmet Ormeci Consultant MEDCER Uluslararasi Medikal Belgelendirme Anonim Sirketi Mevlana Bulvari No:221/141 Yildirim Kule Ankara, Ankara 06830 Turkey
Re: K213775
Trade/Device Name: Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY.LZA Dated: March 24, 2022 Received: April 8, 2022
Dear Mehmet Ormeci:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213775
Device Name
GlovatexTM White Latex Gloves, Glovanil™ Blue Nitrile Gloves
Indications for Use (Describe)
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The Glovanil™ Blue Nittile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination 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) |
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3
510(k) Summary K213775
| 510(k) Submitter Name | AVECENA GLOVES SDN BHD |
|---|---|
| 510(k) Submitter Adress | Lot 50592 Sendayan Techvalley Bandar Sri Sendayan Seremban NEGERI |
| SEMBILAN 71950 NEGERI SEMBILAN, Negeri Sembilan, 71950, MALAYSIA | |
| 510(k) Submitter Telephone No | +60 - 193 - 477659 |
| Primary Correspondent Contact Information | Mehmet Fatih Ormeci (Consultant) |
| +90-532-397-3043 | |
| mformeci@gmail.com | |
| Fax: +90-312-436-08-44 | |
| Summary Preparation Date | 03/24/2022 |
| Trade Or
Proprietary Name | - | Glovatex™ White Latex Gloves
Glovanil™ Blue Nitrile Gloves |
|------------------------------|---|------------------------------------------------------------------------------------|
| Common Name | - | Latex patient examination glove powder free
- Polymer patient examination glove |
| Classification Name | | Non-powder patient examination glove |
| Class | | Class I reserved |
| Product Code | | LYY, LZA |
| | Subject Device 510k
No | Predicate Device 510k
No | Predicate Device
Manufacturer |
|-----------------------------------|---------------------------|-----------------------------|----------------------------------------------------------|
| GlovatexTM White
Latex Gloves | K213775 | K192329 | JR Engineering &
Medical Technologies
(M) SDN.BHD. |
| GlovanilTM Blue Nitrile
Gloves | K213775 | K200326 | Riverstone Resource
Sdn Bhd. |
Device Description
Glovatex™ White Latex Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are in white color, non-sterile and powder free.
Glovanil™ Blue Nitrile Gloves are manufactured to meet all the current specifications listed under the ASTM Specification ASTM D6319 - 19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile compound. These gloves are in Blue color, non-sterile and powder free.
4
Indications For Use/Intended Use Of The Device
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The Glovanil™ Blue Nitrile Glove is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
Technological Characteristics White Latex Gloves
| Characteristics | Standards | Device Performance | Comparison | ||
|---|---|---|---|---|---|
| Predicate | Subject | ||||
| 510(k) number | - | K192329 | K213775 | - | |
| Manufacturer(s) | - | JR Engineering & | |||
| Medical | |||||
| Technologies (M) | |||||
| SDN.BHD. | AVECENA GLOVES SDN | ||||
| BHD | - | ||||
| Name of device | - | Blue Latex | |||
| Examination Powder | |||||
| Free Gloves | Glovatex™ White Latex | ||||
| Gloves | - | ||||
| Product Code | - | LYY | LYY | same | |
| Dimensions- | |||||
| Length | ASTM D3578 |
- 19
Clause 8.4 | Length > 220 mm (small)
Length > 220 mm (medium, large, X-large) | | | Similar |
| | | Size | Average | Size | Average |
| | | Small | 304 | Small | 245 |
| | | Medium | 304 | Medium | 245.6 |
| | | Large | 305 | Large | 247.5 |
| | | X-Large | 305 | X-Large | 244.3 |
| | | XX-Large | 305 | | Not available |
| Dimensions-
Width | ASTM D3578 - 19
Clause 8.4 | Width 70-90mm (small)
Width 85-105mm (medium)
Width 101-121mm (large)
Width 110-130mm (X-large) | | | Similar |
| | | Small | 84 | Small | 84.4 |
| | | Medium | 94 | Medium | 95.3 |
| | | Large | 105 | Large | 103.7 |
| | | X-Large | 114 | X-Large | 111.5 |
| | | XX-Large | 123 | | Not available |
| Dimensions-
Thickness -
Finger | ASTM D3578 - 19
Clause 8.4 | Finger > 0.08 mm | | Finger > 0.08 mm | Similar |
| | | Small | 0.38 | Small | 0.14 |
| | | Medium | 0.38 | Medium | 0.14 |
| | | Large | 0.38 | Large | 0.15 |
| | | X-Large | 0.38 | X-Large | 0.15 |
| | | XX-Large | 0.38 | | Not available |
| Dimensions-
Thickness -
Finger | ASTM D3578 - 19
Clause 8.4 | Palm > 0.08 mm | | Palm > 0.08 mm | Similar |
| | | Small | 0.31 | Small | 0.12 |
| | | Medium | 0.31 | Medium | 0.11 |
| | | Large | 0.31 | Large | 0.11 |
| | | X-Large | 0.31 | X-Large | 0.12 |
| Characteristics | Standards | Device Performance | | Comparison | |
| Physical
Properties-
Tensile Strength | ASTM D3578 - 19
Clause 8.5.1 | Predicate | Subject | Similar | |
| | | XX-Large 0.31 | Not available | | |
| | | Before Ageing
Tensile Strength > 18
Mpa | Before Ageing
Tensile Strength > 18
Mpa | | |
| | | Small 33
Medium 32.9
Large 32.2
X-Large 31.9
XX-Large 31.1 | Small 24.6
Medium 23.1
Large 23.7
X-Large 22
Not available | | |
| | | | | | |
| Physical
Properties-
Tensile Strength | ASTM D3578 - 19
Clause 8.5.2 | After Ageing
Tensile Strength > 14
Mpa | After Ageing
Tensile Strength > 14
Mpa | Similar | |
| | | Small 30
Medium 30.6
Large 29.9
X-Large 29.7
XX-Large 28.2 | Small 23.6
Medium 21.8
Large 20.9
X-Large 22.6
Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Physical
Properties-
Elongation at
Break | ASTM D3578 - 19
Clause 8.5.1 | Before Ageing
Ultimate Elongation
650% | Before Ageing
Ultimate Elongation
650% | Similar | |
| | | Small 1322
Medium 1250
Large 1392
X-Large 1130
XX-Large 1149 | Small 1316
Medium 1346
Large 1330
X-Large 1239
Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Physical
Properties-
Elongation at
Break | ASTM D3578
- 19
Clause 8.5.2 | After Ageing
Ultimate Elongation
500% | After Ageing
Ultimate Elongation
500% | Similar | |
| | | Small 1046
Medium 1122
Large 1257
X-Large 1011
XX-Large 1110 | Small 1356
Medium 1385
Large 1371
X-Large 1340
Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Powder Free
Residue | ASTM D
6124-
06/2017 | ≤2 mg/glove | ≤2 mg/glove | Similar | |
| | | Small 0.20
Medium 0.21
Large 0.22
X-Large 0.22
XX-Large 0.23 | Small 0.39
Medium 0.35
Large 0.37
X-Large 0.42
Not available | | |
| | | | | | |
| | | | | | |
| | | | | | |
| Biocompatibility | In vitro
Cytotoxicity
ISO10993-5
:2009(E) | Non-cytotoxic | Non-cytotoxic | Same | |
| | | | | | |
| | | | | | |
| | | Primary Skin
Not-irritant | Not-irritant | | |
| Characteristics | Standards | Device Performance | | Comparison | |
| | | Predicate | Subject | | |
| | 10993-
10:2010(E)
Dermal
Sensitization-
ISO
10993-
10:2010(E) | Not-sensitizer | Not-sensitizer | | |
| | Material
mediated
Pyrogenicity
ISO 10993-
11:2017(E) /
USP
41 | Non-pyrogenic | Non-pyrogenic | | |
| Freedom From
Holes | ASTM D
5151-19 | Passes | Passes | Same | |
| Intended use | - | Blue Latex
Examination
Powder Free Gloves
are
disposable devices
intended
for medical purpose
that are
worn on the
examiner's hand
to
prevent
contamination
between patient and
examiner. | The Glovatex™ White
Latex Glove is a
disposable device
intended for Medical
purpose that is worn on
the examiner's hands or
finger to prevent
contamination patient
and examiner. | Same | |
| Material | - | Natural Latex | Natural Latex | Same | |
| Color | - | Blue | White | Different | |
| Texture | - | Finger Texture | Finger Texture | Same | |
| Size | ASTM D3578 – 19 | Small, Medium,
Large, X
Large & XX Large | Small, Medium, Large, X
Large | Similar | |
| Single Use | Medical
Glove
Guidance
Manual
- Labeling | Single Use | Single Use | Same | |
| Sterile/non
sterile | - | Non sterile | Non sterile | Same | |
| Powder/Powder
free | - | Powder free | Powder free | Same | |
| Label and
Labeling | FDA Label
requirements | Meets FDA's label
and labeling
requirements | Meets FDA's label
and labeling
requirements | Same | |
5
6
7
Although dimensions, physical properties, powder free residue quantity are slightly different between the predicate device and subject device, both of devices comply with the requirements of ASTM D3578 – 19 and ASTM D 6124-06/2017. The predicate device and subject device has different colors. The predicate device has 5 sizes, on the contrary the subject device has only 4 sizes. The subject device does not include XL size. All other specifications are same between the subject device and predicate device.
Blue Nitrile Glove
| Characteristics | Standards | Device Performance | Comparison | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate | Subject | |||||||||||||||||||||||||||
| 510(k) number | - | K200326 | - | |||||||||||||||||||||||||
| Manufacturer(s) | - | Riverstone Resource Sdn | ||||||||||||||||||||||||||
| Bhd. | AVECENA GLOVES | |||||||||||||||||||||||||||
| SDN BHD | - | |||||||||||||||||||||||||||
| Name of device | - | Powder Free Nitrile | ||||||||||||||||||||||||||
| Examination Glove (Aqua | ||||||||||||||||||||||||||||
| Green) | The Glovanil™ Blue | |||||||||||||||||||||||||||
| Nitrile Glove | - | |||||||||||||||||||||||||||
| Product Code | - | LZA | LZA | same | ||||||||||||||||||||||||
| Dimensions- | ||||||||||||||||||||||||||||
| Length | ASTM D | |||||||||||||||||||||||||||
| 6319-19 | ||||||||||||||||||||||||||||
| (Clause 7.4.2) | Length > 220 mm (small) | |||||||||||||||||||||||||||
| Length > 230 mm (medium, large, X-large) | Similar | |||||||||||||||||||||||||||
| Size Average Small Meet the | ||||||||||||||||||||||||||||
| requirements | ||||||||||||||||||||||||||||
| of ASTM D | ||||||||||||||||||||||||||||
| 6319-19 Medium Large X-Large XX-Large | Size Average Small 239.5 Medium 239.7 Large 238.3 X-Large 239.3 XX-Large Not available | |||||||||||||||||||||||||||
| Dimensions- | ||||||||||||||||||||||||||||
| Width | ASTM D | |||||||||||||||||||||||||||
| 6319-19 | ||||||||||||||||||||||||||||
| (Clause 7.4.3) | Width 70-90mm (small) | |||||||||||||||||||||||||||
| Width 85-105mm (medium) | ||||||||||||||||||||||||||||
| Width 100-120mm (large) | ||||||||||||||||||||||||||||
| Width 110-130mm (X-large) | Similar | |||||||||||||||||||||||||||
| Size Average Small Meet the | ||||||||||||||||||||||||||||
| requirements | ||||||||||||||||||||||||||||
| of ASTM D | ||||||||||||||||||||||||||||
| 6319-19 Medium Large X-Large XX-Large | Size Average Small 81.7 Medium 88.8 Large 104.3 X-Large 111.3 XX-Large Not available | |||||||||||||||||||||||||||
| Dimensions- | ||||||||||||||||||||||||||||
| Thickness - | ||||||||||||||||||||||||||||
| Finger | ASTM D | |||||||||||||||||||||||||||
| 6319-19 | ||||||||||||||||||||||||||||
| (Clause 7.4.4) | Finger > 0.05 mm | Finger > 0.05 mm | Similar | |||||||||||||||||||||||||
| Size Average Small Meet the | ||||||||||||||||||||||||||||
| requirements | ||||||||||||||||||||||||||||
| of ASTM D | ||||||||||||||||||||||||||||
| 6319-19 Medium Large X-Large XX-Large | Size Average Small 0.14 Medium 0.14 Large 0.14 X-Large 0.14 XX-Large Not available | |||||||||||||||||||||||||||
| Dimensions- | ||||||||||||||||||||||||||||
| Thickness - | ||||||||||||||||||||||||||||
| Finger | ASTM D | |||||||||||||||||||||||||||
| 6319-19 | ||||||||||||||||||||||||||||
| (Clause 7.4.4) | Palm > 0.05 mm | Palm > 0.05 mm | Similar | |||||||||||||||||||||||||
| Size Average Small Meet the | ||||||||||||||||||||||||||||
| requirements | ||||||||||||||||||||||||||||
| of ASTM D | ||||||||||||||||||||||||||||
| 6319-19 Medium Large X-Large XX-Large | Size Average Small 0.11 Medium 0.10 Large 0.09 X-Large 0.10 XX-Large Not available | |||||||||||||||||||||||||||
| Before Ageing | Before Ageing | Similar |
8
| Characteristics | Standards | Device Performance | Comparison | ||
|---|---|---|---|---|---|
| Predicate | Subject | ||||
| Physical | |||||
| Properties- | |||||
| Tensile Strength | ASTM D | ||||
| 6319-19 | |||||
| (Clause 7.5.1) | Tensile Strength > 14 | ||||
| Mpa | |||||
| Meet the | |||||
| requirements | |||||
| of ASTM D | |||||
| 6319-19 | Tensile Strength > 14 | ||||
| Mpa | |||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-Large | |||||
| XX-Large | 707 | ||||
| 819 | |||||
| 824 | |||||
| 840 | |||||
| Not available | |||||
| Physical | |||||
| Properties- | |||||
| Tensile Strength | ASTM D | ||||
| 6319-19 | |||||
| (Clause 7.5.1) | After Ageing | ||||
| Tensile Strength > 14 | |||||
| Mpa | |||||
| Meet the | |||||
| requirements | |||||
| of ASTM D | |||||
| 6319-19 | After Ageing | ||||
| Tensile Strength > 14 | |||||
| Mpa | |||||
| Small | |||||
| Medium | |||||
| Large | |||||
| X-Large | |||||
| XX-Large | 22.8 | ||||
| 24.3 | |||||
| 24.0 | |||||
| 22.2 | |||||
| Not available | Similar | ||||
| Physical | |||||
| Properties- | |||||
| Elongation at | |||||
| Break | ASTM D | ||||
| 6319-19 | |||||
| (Clause 7.5.1) | Before Ageing | ||||
| Ultimate Elongation |
500%
Meet the
requirements
of ASTM D
6319-19 | Before Ageing
Ultimate Elongation
500%
Small
Medium
Large
X-Large
XX-Large | 791
848
835
852
Not available | Similar |
| Physical
Properties-
Elongation at
Break | ASTM D
6319-19
(Clause 7.5.1) | After Ageing
Ultimate Elongation
400%
Meet the
requirements
of ASTM D
6319-19 | After Ageing
Ultimate Elongation
400%
Small
Medium
Large
X-Large
XX-Large | 23.6
24.5
24.2
22.1
Not available | Similar |
| Powder Free
Residue | ASTM D
6124-
06/2017 | ≤2 mg/glove
Meet the
requirements
of ASTM D
6124-
06/2017 | ≤2 mg/glove
Small
Medium
Large
X-Large
XX-Large | 1.18
1.91
0.81
1.17
Not available | Similar |
| Biocompatibility | In vitro
Cytotoxicity
ISO10993-5
Primary Skin
Irritation-ISO
10993-10
Dermal
Sensitization-
ISO | No information | Non-cytotoxic | | Similar |
| | | Not-irritant | Not-irritant | | |
| | | Not-sensitizer | Not-sensitizer | | |
| Characteristics | Standards | Device Performance | | Comparison | |
| | | Predicate | Subject | | |
| | 10993-10
Acute
Systemic Test
ISO 10993-11 | Did not induce a systemic
toxicity | Did not induce a
systemic toxicity | | |
| | Material
mediated
Pyrogenicity
ISO 10993-
11/ USP
41 | / | Did not produce a
pyrogenic response | Different | |
| Freedom From
Holes | ASTM D
5151-19 | Passes | Passes | Same | |
| 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 overthe-
counter use. | The GlovanilTM Blue
Nitrile Glove is a
disposable device
intended for Medical
purpose that is worn
on the examiner's
hands or finger to
prevent
contamination
patient and
examiner. | Same | |
| Material | - | Nitrile compound | Nitrile compound | Same | |
| Color | - | Aqua Green | Blue | Different | |
| Size | ASTM D6319 - 19 | Small, Medium, Large, X
Large & XX Large | Small, Medium,
Large, X
Large | Similar | |
| Single Use | Medical
Glove
Guidance
Manual
- Labeling | Single Use | Single Use | Same | |
| Sterile/non
sterile | - | Non sterile | Non sterile | Same | |
| Powder/Powder
free | | Powder free | Powder free | Same | |
| Label and
Labeling | FDA Label
requirements | Meets FDA's label
and labeling
requirements | Meets FDA's label
and labeling
requirements | Same | |
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Although dimensions, physical properties, powder free residue quantity are slightly different between the predicate device and subject device, both of devices comply with the requirements of ASTM D6319-10 and ASTM D 6124-06/2017. The predicate device and subject device has different colors. The predicate device has 5 sizes, on the contrary the subject device has only 4 sizes. The subject device does not include XL size. More biocompatibility tests were performed to subject device compared to
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predicate device. Both devices meet the requirements of ISO 10993-1. All other specifications are same between the subject device and predicate devices.
Summary of Non-Clinical Testing
The Glovatex™ White Latex Gloves meet the requirements of ASTM D3578 - 19, ASTM D 6124-06(2017), ISO10993-5:2009(E), ISO 10993-10:2010(E), ISO 10993-11:2017(E), USP 41 and ASTM D 5151-19.
The Glovanil™ Blue Nitrile Gloves meet the requirements of ASTM D 6319-19, ASTM D 6124-06(2017), ISO10993-5:2009(E), ISO 10993-10:2010(E), ISO 10993-11:2017(E), USP 41 and ASTM D 5151-19.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the Glovatex™ White Latex Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K192329.
The conclusion drawn from the nonclinical tests demonstrates that the GlovaniI™ Blue Nitrile Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K200326.