(227 days)
Not Found
No
The device description and performance studies focus on the physical properties and material composition of examination gloves, with no mention of AI or ML technologies.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
This device is a patient examination glove, described as a disposable device worn on the hand to prevent contamination. Its function is protective, not diagnostic.
No
The device is a physical glove, not software. The description details material composition, manufacturing process, and physical characteristics.
Based on the provided information, 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 used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical characteristics and manufacturing process of a glove. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Any of the typical components or processes associated with IVD devices (reagents, assays, analyzers, etc.)
In summary, the device is a medical glove used for barrier protection, which falls under a different regulatory classification than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
It is a powder-free chloroprene patient examination gloves made by on-line polymer-coating and mild on-line chlorination process. The process modifies the surface characteristics without the use of any dusting or donning powder. The gloves are non-sterile, disposable and for single use only.
Characteristics:
- Ambidextrous with beaded cuff
- Blended synthetic latex (Chloroprene and Nitrile Latex)
- Blue or green Coloured
- Five sizes: X-Small, Small, Medium, Large and X-Large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing
Following is a table showing the actual measured parameters of the gloves (e.g. length, thickness, width, physical properties, etc.) as compare to ASTM. All data meets the standard reference requirement.
Test: Freedom From Holes; Standard: ASTM D6977-19 ASTM D5151-19; Acceptance Criteria: Meet requirement inspection level G-I, AQL 2.5; Result: Pass
Test: Dimension; Standard: ASTM D6977-19; Result: Pass
Size: XSmall, Small, Medium, Large, XLarge
Length, min. mm: XSmall (220), Medium (230)
Thickness, min. mm: 0.05
Width, +/- 10 mm: XSmall (70), Small (80), Medium (95), Large (110), XLarge (120)
Test: Physical Properties; Standard: ASTM D6977-19; Result: Pass
Before Aging: Tensile Strength 14 MPa min., Ultimate Elongation 500 % min.
After Accelerated Aging: Tensile Strength 14 MPa min., Ultimate Elongation 400 % min.
Test: Residual Powder Content; Standard: ASTM D6977-19 ASTM D6124-06; Acceptance Criteria: Not more than 2 mg per glove; Result: Pass
Test: Biocompatibility
i) Primary Skin Irritation Test; Standard: ISO 10993-5; Acceptance Criteria: No Animal Irritation; Result: Pass
ii) Skin Sensitization Test; Standard: ISO 10993-10; Acceptance Criteria: No Animal Irritation; Result: Pass
iii) In Vitro Cytotoxicity; Standard: ISO 10993-5; Acceptance Criteria: No cytotoxicity reactivity at 100.0% extract concentrations under the conditions of this test; Result: The test material exhibited cytotoxicity response at 100% of extract concentration
iv) Acute Systemic Toxicity; Standard: ISO 10993-11; Acceptance Criteria: No adverse biological reaction; Result: Pass
Summary of Clinical Testing: Not applicable
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.
August 5, 2022
Careglove Global SDN BHD Lim Kwee Shyan Official Correspondent Lot 17479, Lorong Senawang 2/3, Off Jalan Senawang 3, Senewang Industrial Estate Seremban, Negeri Sembilan Darul Khusus 70450 Malaysia
Re: K213993
Trade/Device Name: Chloroprene Examination Glove Powder Free (Blue, Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: Class I, reserved Product Code: LZA, Dated: June 24, 2022 Received: July 6, 2022
Dear Lim Kwee Shyan:
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.
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 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 mediation-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.
Bifeng Oian, M.D., Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213993
Device Name
Chloroprene Examination Gloves Powder Free (Blue, Green)
Indications for Use (Describe)
A 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
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
FORM FDA 3881 (6/20)
3
Image /page/3/Picture/0 description: The image is a logo with a white square background and a thin black border. Inside the square, there is a gray vertical rectangle on the left side, and a red semi-circle on the right side. The semi-circle is positioned such that its flat edge aligns with the right edge of the gray rectangle, creating a shape that resembles the letter 'P'.
OVE GLOBAL SDN B (Co. No : 933760-W)
Off Jalan Senawang 3, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Email: info@careglove.com -678 2377 Fax: 60-6-678 5377 Website : www.careplus.com
Quality and Relationship You Can Trust
510(K) SUMMARY
| 510(K) No. | K213993 |
|---|---|
| Applicant | Careglove Global Sdn Bhd |
| Location | Lot 17479, Lorong Senawang 2/3 |
| Off Jalan Senawang 3, | |
| Senawang Industrial Estate, | |
| 70450 Seremban, | |
| Negeri Sembilan Darul Khusus, | |
| Malaysia. | |
| Phone No. | (60) 6 6782377 |
| Fax No. | (60) 6 6785377 |
| Contact Person | Lim Kwee Shyan |
| Summary Preparation Date | August 5, 2022 |
| Device Information | |
|---|---|
| Trade Name | : Chloroprene Examination Gloves Powder Free (Blue, Green) |
|---|---|
| Common Name | : Chloroprene Examination Gloves Powder Free |
| Classification Name | : Patient Examination Gloves |
| Device Class | : I |
| Product Code | : LZA |
| Regulation | : 21 CFR 880.6250 |
Predicate Device
510(K) number K171743, Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves.
Device Description
It is a powder-free chloroprene patient examination gloves made by on-line polymer-coating and mild on-line chlorination process. The process modifies the surface characteristics without the use of any dusting or donning powder. The gloves are non-sterile, disposable and for single use only.
Characteristics:
- Ambidextrous with beaded cuff
- Blended synthetic latex (Chloroprene and Nitrile Latex)
- Blue or green Coloured ●
- Five sizes: X-Small, Small, Medium, Large and X-Large. ●
Intended Use of Device / Indications for Use
A 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.
4
Image /page/4/Picture/0 description: The image is a logo with a white square background and a black border. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The gray rectangle and the red semi-circle are positioned to resemble the letter 'P'.
Lot 17479, Lorong ട്ടല്ലുക്കുവും 3/2 Off Jalan Senawang 3, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Qarul പ്രവ്യുന്നു. Malaysia. Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com Website : www.careplus.com
Quality and Relationship You Can Trust
Comparison of the technological characteristic between the predicate and subject devices
The Chloroprene Examination Gloves Powder Free (Blue), are summarized with the following technological characteristics compared to ASTM D6977 or equivalent standards.
| Characteristic | Standard | Specification | Subject Device
Chloroprene
Examination
Gloves Powder
Free (Blue,
Green), 510(k)
Number K213993 | Predicate Device
Powder Free Pink
Polychloroprene
Copolymer Examination
Gloves, Powder Free
Black Polychloroprene
Copolymer Examination
Gloves, 510(k) Number
K171743 | Remark |
|------------------------|----------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | - | - | LZA | LZA | Same |
| Intended Use | - | - | Intended for
medical purposes
that is worn on the
examiner's hand or
finger 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 |
| Design | - | - | Powder Free, Non-
Sterile,
Ambidextrous,
Beaded Cuff | Powder Free, Non-Sterile,
Ambidextrous, Beaded Cuff | Same |
| Indications for
Use | - | - | A 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 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 | Same |
5
Image /page/5/Picture/0 description: The image is a logo that features a white square with a thick black border. Inside the square, there is a gray vertical rectangle on the left side, and a red semi-circle on the right side. The gray rectangle and the red semi-circle are positioned next to each other, creating a visual representation of the letter 'P'.
CAREGLOVE GLOBAL SDN BHD co. ₪ 33760-w/
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan ழூரபூ ്ല്യുട്ടുട്ടു, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com Website : www.careplus.com
| Quality and Relationship You Can Trust | |||||
|---|---|---|---|---|---|
| Characteristic | Standard | Specification | Subject Device | ||
| Chloroprene | |||||
| Examination | |||||
| Gloves Powder | |||||
| Free (Blue, Green) | |||||
| 510(k) Number | |||||
| K213993 | Predicate Device | ||||
| Powder Free Pink | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination Gloves, | |||||
| Powder Free Black | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination Gloves, | |||||
| 510(k) Number | |||||
| K171743 | Remark | ||||
| Construction | - | - | Ambidextrous, | ||
| Polymer Coated or | |||||
| Chlorinated, Powder | |||||
| Free Nitrile | Ambidextrous, | ||||
| Polyacrylic Polymer | |||||
| Inner Coating, Powder | |||||
| Free Nitrile | Similar | ||||
| Color | |||||
| Description | - | - | Blue | Pink, Black | Different |
| Material | - | - | Mixture of Nitrile and | ||
| Chloroprene | Polychloroprene | Different | |||
| Single Use | - | - | Yes | Yes | Same |
| Packaging | - | - | Packed in Dispenser | ||
| Boxes | Packed in Dispenser | ||||
| Boxes | Same | ||||
| Characteristic | Standards | Related Defects | Subject Device | ||
| Chloroprene | |||||
| Examination | |||||
| Gloves Powder | |||||
| Free (Blue, Green) | |||||
| 510(k) Number | |||||
| K213993 | Predicate Device | ||||
| Powder Free Pink | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination | |||||
| Gloves, Powder | |||||
| Free Black | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination | |||||
| Gloves, 510(k) | |||||
| Number K171743 | Remark | ||||
| Dimension | |||||
| Length (size: XSmall), | |||||
| mm | ASTM | ||||
| D6977-19 | 220 min | Meet 220mm min | Meet 220mm min | Similar | |
| Length (size: Small), mm | 220 min | Meet 220mm min | Meet 220mm min | ||
| Length (size: Medium), | |||||
| mm | 230 min | Meet 230mm min | Meet 230mm min | ||
| Length (size: Large), mm | 230 min | Meet 230mm min | Meet 230mm min | ||
| Length (size: XLarge), | |||||
| mm | 230 min | Meet 230mm min | Meet 230mm min | ||
| Thickness (palm), mm | |||||
| Thickness (finger), mm | 0.05 min | ||||
| 0.05 min | Meet 0.05mm min | ||||
| Meet 0.05mm min | Meet 0.05mm min | ||||
| Meet 0.05mm min | |||||
| Width (size: XSmall), | |||||
| mm | 70 ± 10 | Meet 70 ± 10 mm | Meet 70 ± 10 mm | ||
| Width (size: Small), mm | 80 ± 10 | Meet 80 ± 10 mm | Meet 80 ± 10 mm | ||
| Width (size: Medium), | |||||
| mm | 95 ± 10 | Meet 95 ± 10 mm | Meet 95 ± 10 mm | ||
| Width (size: Large), mm | 110 ± 10 | Meet 110 ± 10 mm | Meet 110 ± 10 mm | ||
| Width (size: XLarge), | |||||
| mm | 120 ± 10 | Meet 120 ± 10 mm | Meet 120 ± 10 mm | ||
| Physical Properties | |||||
| (Before Aging) | |||||
| i) Tensile Strength (MPa) | ASTM | ||||
| D6977-19 | Min. 14 | Meet 14MPa min | Meet 14MPa min. | Similar | |
| ii) Ultimate Elongation | |||||
| (%) | Min. 500 | Meet 500% min | Meet 500% min | ||
| (After Aging) | |||||
| i) Tensile Strength | |||||
| (MPa) | Min. 14 | Meets 14MPa min | Meets 14MPa min | ||
| ii) Ultimate Elongation | |||||
| (%) | Min. 400 | Meet 400% min. | Meet 400% min. | ||
| Characteristic | Standards | Related | |||
| Defects | Subject Device | ||||
| Chloroprene | |||||
| Examination | |||||
| Gloves Powder | |||||
| Free (Blue, Green) | |||||
| 510(k) Number | |||||
| K213993 | Predicate Device | ||||
| Powder Free Pink | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination | |||||
| Gloves, Powder | |||||
| Free Black | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination | |||||
| Gloves, 510(k) | |||||
| Number K171743 | Remark | ||||
| Water Leak Test, | |||||
| 1000 ml | |||||
| Before Aging, AQL | ASTM D6977- | ||||
| 19 | G- I, AQL 2.5 | ||||
| (FDA GII, AQL | Meet AQL 1.5 | Meet AQL 1.5 | Similar | ||
| After Aging, AQL | ASTM D5151- | ||||
| 19 | 2.5) | Meet AQL 2.5 | Meet AQL 2.5 | Similar | |
| Powder Free Residue | |||||
| Powder Free Residue, | |||||
| mg/glove | ASTM D6977- | ||||
| 19 | |||||
| ASTM D6124- | |||||
| 06 | Max. | ||||
| 2mg/glove | Meet 2mg/glove | ||||
| max. | Meet 2mg/glove | ||||
| max | Similar | ||||
| Biocompatibility Test | |||||
| i) Primary Skin Irritation | |||||
| Test | ISO 10993-10 | No Animal | |||
| Irritation | Passes | ||||
| i) Primary Skin | |||||
| Irritation Test. | |||||
| Conclusion: Under | |||||
| the conditions of this | |||||
| study the test | |||||
| material did not | |||||
| cause an irritant | |||||
| response | Passes | ||||
| i)Primary Skin | |||||
| Irritation Test. | |||||
| Conclusion: Under | |||||
| the conditions of | |||||
| the study, not an | |||||
| irritant | Same | ||||
| ii)Skin Sensitization | |||||
| Test | ISO 10993-10 | No Animal | |||
| Irritation | ii)Dermal | ||||
| Sensitization | |||||
| Test. | |||||
| Conclusion: Under | |||||
| the conditions of this | |||||
| study, the test | |||||
| material did not | |||||
| produce a skin | |||||
| sensitization effect | ii)Dermal | ||||
| Sensitization | |||||
| Test. | |||||
| Conclusion: Under | |||||
| the conditions of | |||||
| the study, not a | |||||
| sensitizer | Same | ||||
| Characteristic | Standards | Related | |||
| Defects | Subject Device | ||||
| Chloroprene | |||||
| Examination | |||||
| Gloves Powder | |||||
| Free (Blue, Green) | |||||
| 510(k) Number | |||||
| K213993 | Predicate Device | ||||
| Powder Free Pink | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination | |||||
| Gloves, Powder | |||||
| Free Black | |||||
| Polychloroprene | |||||
| Copolymer | |||||
| Examination | |||||
| Gloves, 510(k) | |||||
| Number K171743 | Remark | ||||
| Biocompatibility Test | - | ||||
| iii) In Vitro Cytotoxicity | ISO 10993-5 | - | iii) In Vitro | ||
| Cytotoxicity Test. | |||||
| Conclusion: | |||||
| Under the conditions | |||||
| of this study, the test | |||||
| material exhibited | |||||
| cytotoxicity response | |||||
| at 100% of extract | |||||
| concentration. | iii) No Information | Different | |||
| iv) Acute Systemic | |||||
| Toxicity | ISO 10993-11 | - | iv) Acute Systemic | ||
| Toxicity | |||||
| Conclusion: | |||||
| Under the condition | |||||
| of this study, the test | |||||
| material showed no | |||||
| adverse biological | |||||
| reaction after | |||||
| administration of the | |||||
| sample's extract on | |||||
| the rats during the | |||||
| period of the study. | iv) No Information | Different |
6
Image /page/6/Picture/0 description: The image is a logo that features a white square with a thick black border. Inside the square, there is a gray vertical rectangle on the left side, and a red semi-circle on the right side. The gray rectangle and the red semi-circle are positioned next to each other, creating a visual representation of the letter 'P'.
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan Qarul Khusus, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com
Website : www.careplus.com
7
Image /page/7/Picture/0 description: The image is a logo that features a stylized letter "P" within a square. The left side of the "P" is a gray rectangle, while the right side is a red semi-circle. The background of the logo is white, and there is a subtle drop shadow effect around the square, giving it a slightly three-dimensional appearance. The design is simple and modern, using contrasting colors to make the "P" stand out.
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan Qarul Khusus, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com
Website : www.careplus.com
8
Image /page/8/Picture/0 description: The image is a logo with a white square background and a black border. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The gray rectangle and the red semi-circle are positioned next to each other, forming a shape that resembles the letter 'P'.
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan Qarul Khusus, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com
Website : www.careplus.com
9
Image /page/9/Picture/0 description: The image is a logo with a white square background and a thick black border. Inside the square, there is a gray vertical rectangle on the left side, taking up about a third of the space. To the right of the gray rectangle, there is a red semi-circle that resembles the letter 'P'. The red semi-circle is positioned so that its flat edge aligns with the right edge of the gray rectangle, creating a visual representation of the letter 'P'.
Lot 17479, Lorong Senawang 3/2
Off Jalan Senawang 3, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com Website : www.careplus.com
Quality and Relationship You Can Trust
The Chloroprene Examination Gloves Powder Free (Green), are summarized with the following technological characteristic compared to ASTM D6977 or equivalent standards.
| Characteristic | Standard | Specification | Subject Device
Chloroprene
Examination
Gloves Powder
Free (Blue,
Green) 510(k)
Number K213993 | Predicate Device
Powder Free Pink
Polychloroprene
Copolymer Examination
Gloves, Powder Free
Black Polychloroprene
Copolymer Examination
Gloves, 510(k) Number
K171743 | Remark |
|------------------------|----------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | - | - | LZA | LZA | Same |
| Intended Use | - | - | Intended for
medical purposes
that is worn on the
examiner's hand or
finger 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 |
| Design | - | - | Powder Free, Non-
Sterile,
Ambidextrous,
Beaded Cuff | Powder Free, Non-Sterile,
Ambidextrous, Beaded
Cuff | Same |
| Indications for
Use | - | - | A 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 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 | Same |
10
Image /page/10/Picture/0 description: The image is a logo that features a white square with a thick black border. Inside the square, there is a gray vertical rectangle on the left side, and a red semi-circle on the right side. The gray rectangle and the red semi-circle are positioned next to each other, creating a visual representation of the letter 'P'.
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan Qarul Khusus, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com Website : www.careplus.com
| Characteristic | Standard | Specification | Subject Device
Chloroprene
Examination
Gloves Powder
Free (Blue,
Green) 510(k)
Number
K213993 | Predicate Device
Powder Free Pink
Polychloroprene
Copolymer Examination
Gloves, Powder Free
Black Polychloroprene
Copolymer Examination
Gloves, 510(k) Number
K171743 | Remark |
|-----------------------------------------------------|----------------------------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Construction | - | - | Ambidextrous,
Polymer Coated
or Chlorinated,
Powder Free
Nitrile | Ambidextrous, Polyacrylic
Polymer Inner Coating,
Powder Free Nitrile | Similar |
| Color
Description | - | - | Green | Pink, Black | Different |
| Material | - | - | Mixture of Nitrile
and Chloroprene | Polychloroprene | Different |
| Single Use | - | - | Yes | Yes | Same |
| Packaging | - | - | Packed in
Dispenser Boxes | Packed in Dispenser Boxes | Same |
| Characteristic | Standards | Related Defects | Subject Device
Chloroprene
Examination
Gloves Powder Free
(Blue, Green) 510(k)
Number K213993 | Predicate Device
Powder Free Pink
Polychloroprene
Copolymer
Examination Gloves,
Powder Free Black
Polychloroprene
Copolymer
Examination Gloves,
510(k) Number
K171743 | Remark |
| Dimension | | | | | |
| Length (size: XSmall),
mm | ASTM
D6977-19 | 220 min | Meet 220mm min | Meet 220mm min | Similar |
| Length (size: Small), mm | | 220 min | Meet 220mm min | Meet 220mm min | |
| Length (size: Medium),
mm | | 230 min | Meet 230mm min | Meet 230mm min | |
| Length (size: Large), mm | | 230 min | Meet 230mm min | Meet 230mm min | |
| Length (size: XLarge),
mm | | 230 min | Meet 230mm min | Meet 230mm min | |
| Thickness (palm), mm
Thickness (finger), mm | | 0.05 min
0.05 min | Meet 0.05mm min
Meet 0.05mm min | Meet 0.05mm min
Meet 0.05mm min | |
| Width (size: XSmall),
mm | | 70 ± 10 | Meet 70 ± 10 mm | Meet 70 ± 10 mm | |
| Width (size: Small), mm | | 80 ± 10 | Meet 80 ± 10 mm | Meet 80 ± 10 mm | |
| Width (size: Medium),
mm | | 95 ± 10 | Meet 95 ± 10 mm | Meet 95 ± 10 mm | |
| Width (size: Large), mm | | 110 ± 10 | Meet 110 ± 10 mm | Meet 110 ± 10 mm | |
| Width (size: XLarge),
mm | | 120 ± 10 | Meet 120 ± 10 mm | Meet 120 ± 10 mm | |
| Physical Properties | | | | | |
| (Before Ageing)
i) Tensile Strength (MPa) | ASTM
D6977-19 | Min. 14 | Meet 14MPa min | Meet 14MPa min. | Similar |
| ii) Ultimate Elongation
(%) | | Min. 500 | Meet 500% min | Meet 500% min | |
| (After Aging)
i) Tensile Strength
(MPa) | | Min. 14 | Meets 14MPa min | Meets 14MPa min | |
| ii) Ultimate Elongation
(%) | | Min. 400 | Meet 400% min. | Meet 400% min. | |
| Characteristic | Standards | Related Defects | Subject Device
Chloroprene
Examination
Gloves Powder
Free (Blue, Green)
510(k) Number
K213993 | Predicate Device
Powder Free Pink
Polychloroprene
Copolymer
Examination
Gloves, Powder
Free Black
Polychloroprene
Copolymer
Examination
Gloves, 510(k)
Number K171743 | Remark |
| Water Leak Test,
1000 ml | | | | | |
| Before Aging, AQL | ASTM D6977-
19 | G- I, AQL 2.5
(FDA GII, AQL | Meet AQL 1.5 | Meet AQL 1.5 | Similar |
| After Aging, AQL | ASTM D5151-
19 | 2.5) | Meet AQL 2.5 | Meet AQL 2.5 | |
| Powder Free Residue | | | | | |
| Powder Free Residue,
mg/glove | ASTM D6977-
19
ASTM D6124-
06 | Max.
2mg/glove | Meet 2mg/glove
max. | Meet 2mg/glove
max | Similar |
| Biocompatibility Test | | | | | |
| i) Primary Skin Irritation
Test | ISO 10993-10 | No Animal
Irritation | Passes
i) Primary Skin
Irritation Test.
Conclusion: Under
the conditions of this
study the test
material did not
cause an irritant
response | Passes
i)Primary Skin
Irritation Test.
Conclusion: Under
the conditions of
the study, not an
irritant | Same |
| ii)Skin Sensitization
Test | ISO 10993-10 | No Animal
Irritation | ii)Dermal
Sensitization
Test.
Conclusion: Under
the conditions of this
study, the test
material did not
produce a skin
sensitization effect | ii)Dermal
Sensitization
Test.
Conclusion: Under
the conditions of
the study, not a
sensitizer | Same |
| Characteristic | Standards | Related
Defects | Subject Device
Chloroprene
Examination
Gloves Powder
Free (Blue, Green)
510(k) Number
K213993 | Predicate Device
Powder Free Pink
Polychloroprene
Copolymer
Examination
Gloves, Powder
Free Black
Polychloroprene
Copolymer
Examination
Gloves, 510(k)
Number K171743 | Remark |
| Biocompatibility Test
iii) In Vitro Cytotoxicity | ISO 10993-5 | - | iii) In Vitro
Cytotoxicity Test.
Conclusion:
Under the conditions
of this study, the test
material exhibited
cytotoxicity response
at 100% of extract
concentration. | iii) No Information | Different |
| iv) Acute Systemic
Toxicity | ISO 10993-11 | - | iv) Acute Systemic
Toxicity
Conclusion:
Under the condition
of this study, the test
material showed no
adverse biological
reaction after
administration of the
sample's extract on
the rats during the
period of the study. | iv) No Information | Different |
11
Image /page/11/Picture/0 description: The image is a logo with a white square background. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The gray rectangle and the red semi-circle are positioned next to each other, creating a visual representation of the letter 'P'.
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan Qarul Khusus, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com
Website : www.careplus.com
12
Image /page/12/Picture/0 description: The image is a logo that features a stylized letter "P" within a square. The left side of the "P" is a gray rectangle, while the right side is a red semi-circle. The background of the logo is white, and there is a subtle drop shadow effect around the square, giving it a slightly three-dimensional appearance. The design is simple and modern, using contrasting colors to make the "P" stand out.
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan Qarul Khusus, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com
Website : www.careplus.com
13
Image /page/13/Picture/0 description: The image is a logo that features a white square with a thick black border. Inside the square, there is a gray vertical rectangle on the left side and a red semi-circle on the right side. The gray rectangle and red semi-circle are positioned next to each other, creating a visual contrast within the square. The logo appears to be a stylized representation of the letter 'P'.
Lot 17479, Lorong ડ્રેશ્વરમાંથી 3/2
Off Jalan Senawang 3, Senawang Jndustrial Estate
70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com
Website : www.careplus.com
14
Image /page/14/Picture/0 description: The image is a logo that features a white square with a gray rectangle on the left side and a red semi-circle on the right side. The gray rectangle is positioned vertically and takes up about one-third of the square's width. The red semi-circle is placed adjacent to the rectangle and occupies the remaining space on the right side of the square. The logo has a simple and modern design.
Off Jalan Senawang 3, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan ປຼລກມູ Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com Website : www.careplus.com
Quality and Relationship You Can Trust
Summary of Non-Clinical Testing
Lot 17479, Lorong ട്ടല്ലുക്കുവും 3/2
Following is a table showing the actual measured parameters of the gloves (e.g. length, thickness, width, physical properties, etc.) as compare to ASTM. All data meets the standard reference requirement.
| Test | Standard | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|
| Freedom From Holes | ASTM D6977-19 | ||||||
| ASTM D5151-19 | Meet requirement inspection level G-I, AQL 2.5 | Pass | |||||
| Dimension | ASTM D6977-19 | Pass | |||||
| Size | XSmall | Small | Medium | Large | XLarge | ||
| Length, min. mm | 220 | 230 | |||||
| Thickness, min. mm | 0.05 | ||||||
| Width, ± 10 mm | 70 | 80 | 95 | 110 | 120 | ||
| Physical Properties | ASTM D6977-19 | Pass | |||||
| Before Aging | After Accelerated Aging | ||||||
| Tensile Strength | |||||||
| 14 MPa min. | Ultimate Elongation | ||||||
| 500 % min. | Tensile Strength | ||||||
| 14 MPa min. | Ultimate Elongation | ||||||
| 400 % min. | |||||||
| Residual Powder Content | ASTM D6977-19 | ||||||
| ASTM D6124-06 | Not more than 2 mg per glove | Pass | |||||
| Biocompatibility | |||||||
| i) Primary Skin Irritation Test | ISO 10993-5 | No Animal Irritation | Pass | ||||
| ii) Skin Sensitization Test | ISO 10993-10 | No Animal Irritation | Pass | ||||
| iii) In Vitro Cytotoxicity | ISO 10993-5 | No cytotoxicity reactivity at 100.0% extract concentrations under the conditions of this test | The test material exhibited cytotoxicity response at 100% of extract concentration | ||||
| iv) Acute Systemic Toxicity | ISO 10993-11 | No adverse biological reaction | Pass |
15
Image /page/15/Picture/0 description: The image is a logo that features a white square with a thick black border. Inside the square, there is a gray vertical rectangle on the left side, taking up about a third of the square's width. To the right of the gray rectangle, there is a red semi-circle that resembles the letter 'P'. The red semi-circle is positioned so that its flat edge aligns with the right edge of the gray rectangle, creating a visual interplay between the two shapes.
CAREGLOVE GLOBAL SDN BHD (co. Mo : 933760-W)
Lot 17479, Lorong ട്ടല്ലുമുഴുന്നു, 3/2 Off Jalan Se̯ṇawaŋɡ̥ 3, Senawaṇɡ Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia. Tel: 60-6-678 2377 Fax: 60-6-678 5377 Email: info@careglove.com Website : www.careplus.com
Quality and Relationship You Can Trust
Summary of Clinical Testing
Not applicable
Conclusions:
The conclusions drawn from the non-clinical tests demonstrate that the subject device, Chloroprene Examination Gloves Powder Free (Blue, Green), is as safe, as effective, and performs as well as or better than the legally marketed device, Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves, 510(k) number K171743.