(227 days)
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
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. ●
The provided document is a 510(k) Premarket Notification for Chloroprene Examination Gloves Powder Free (Blue, Green). This document focuses on demonstrating substantial equivalence to a predicate device, which involves comparing material, design, and performance characteristics for a medical device (examination gloves), not an AI/ML-driven device.
Therefore, the requested information regarding AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this document.
What the document does provide is a detailed comparison of the physical and biological characteristics of the proposed gloves against established ASTM standards and the predicate device.
Here's a summary of the acceptance criteria and reported performance for the Chloroprene Examination Gloves Powder Free (Blue, Green), as extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance (Subject Device K213993) |
|---|---|---|---|
| Product Code | - | LZA (Same as predicate) | LZA |
| Intended Use | - | Intended for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner (Same as predicate) | Intended for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner |
| Design | - | Powder Free, Non-Sterile, Ambidextrous, Beaded Cuff (Same as predicate) | Powder Free, Non-Sterile, Ambidextrous, Beaded Cuff |
| 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 (Same as predicate) | 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 |
| Construction | - | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile (Similar to predicate's Ambidextrous, Polyacrylic Polymer Inner Coating, Powder Free Nitrile) | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile |
| Single Use | - | Yes (Same as predicate) | Yes |
| Packaging | - | Packed in Dispenser Boxes (Same as predicate) | Packed in Dispenser Boxes |
| Dimension (Length) | ASTM D6977-19 | XSmall, Small: 220 mm minMedium, Large, XLarge: 230 mm min | Meet 220mm min (XSmall, Small)Meet 230mm min (Medium, Large, XLarge) |
| Dimension (Thickness) | ASTM D6977-19 | Palm: 0.05 mm minFinger: 0.05 mm min | Meet 0.05mm min (Palm)Meet 0.05mm min (Finger) |
| Dimension (Width) | ASTM D6977-19 | XSmall: 70 ± 10 mmSmall: 80 ± 10 mmMedium: 95 ± 10 mmLarge: 110 ± 10 mmXLarge: 120 ± 10 mm | Meet 70 ± 10 mm (XSmall)Meet 80 ± 10 mm (Small)Meet 95 ± 10 mm (Medium)Meet 110 ± 10 mm (Large)Meet 120 ± 10 mm (XLarge) |
| Physical Properties (Before Aging) | ASTM D6977-19 | Tensile Strength: Min. 14 MPaUltimate Elongation: Min. 500% | Meet 14MPa minMeet 500% min |
| Physical Properties (After Aging) | ASTM D6977-19 | Tensile Strength: Min. 14 MPaUltimate Elongation: Min. 400% | Meets 14MPa minMeet 400% min. |
| Water Leak Test (Before Aging) | ASTM D6977-19 | G-I, AQL 2.5 (FDA GII, AQL 2.5) | Meet AQL 1.5 |
| Water Leak Test (After Aging) | ASTM D5151-19 | (Assumed same as Before Aging in this context - AQL 2.5 for general examination gloves) | Meet AQL 2.5 |
| Powder Free Residue | ASTM D6977-19ASTM D6124-06 | Max. 2 mg/glove | Meet 2mg/glove max. |
| Biocompatibility: Primary Skin Irritation Test | ISO 10993-10 | No Animal Irritation | Passes. Conclusion: Did not cause an irritant response. |
| Biocompatibility: Skin Sensitization Test | ISO 10993-10 | No Animal Irritation (No sensitization effect) | Passes. Conclusion: Did not produce a skin sensitization effect. |
| Biocompatibility: In Vitro Cytotoxicity | ISO 10993-5 | No cytotoxicity reactivity at 100.0% extract concentrations under the conditions of this test | Exhibited cytotoxicity response at 100% of extract concentration. (Remarked as "Different" compared to predicate which had "No Information") – It still passed the overall safety conclusion. |
| Biocompatibility: Acute Systemic Toxicity | ISO 10993-11 | No adverse biological reaction | Passed. Conclusion: Showed no adverse biological reaction. (Remarked as "Different" compared to predicate which had "No Information") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a single "test set" sample size for a clinical study. The data presented are results of various laboratory and biocompatibility tests on the gloves. These tests typically involve a specific number of gloves or samples per test as per the ASTM and ISO standards referenced (e.g., AQL for water leak tests, specific batches for physical property tests). The exact number of gloves or samples for each test is not detailed in this summary, but the results confirm they "Meet" or "Pass" the specified standards.
- Data Provenance: The manufacturer is Careglove Global SDN BHD, located in Malaysia. The testing was conducted to comply with international standards (ASTM and ISO). The document does not specify whether the data is retrospective or prospective in the context of a clinical trial, as this is a premarket notification for a Class I general medical device based on engineering and biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a physical medical device (examination gloves) where "ground truth" is established through adherence to standardized laboratory test methods (ASTM, ISO) for physical properties and biocompatibility, not by expert interpretation of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, this is a physical device tested against objective standards, not an AI/ML system requiring human expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on objective measurements defined by international standards (ASTM D6977-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-10, ISO 10993-5, ISO 10993-11) for physical properties (e.g., length, thickness, tensile strength, elongation, freedom from holes, powder residue) and biocompatibility (e.g., skin irritation, sensitization, cytotoxicity, systemic toxicity).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device; there is no "training set" or establishment of ground truth in that context.
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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.
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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
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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)
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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 2/3Off 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.
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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 DeviceChloropreneExaminationGloves PowderFree (Blue,Green), 510(k)Number K213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymer ExaminationGloves, Powder FreeBlack PolychloropreneCopolymer ExaminationGloves, 510(k) NumberK171743 | Remark |
|---|---|---|---|---|---|
| Product Code | - | - | LZA | LZA | Same |
| Intended Use | - | - | Intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner | Intended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner | Same |
| Design | - | - | Powder Free, Non-Sterile,Ambidextrous,Beaded Cuff | Powder Free, Non-Sterile,Ambidextrous, Beaded Cuff | Same |
| Indications forUse | - | - | A patientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner | Same |
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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 DeviceChloropreneExaminationGloves PowderFree (Blue, Green)510(k) NumberK213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymerExamination Gloves,Powder Free BlackPolychloropreneCopolymerExamination Gloves,510(k) NumberK171743 | Remark |
| Construction | - | - | Ambidextrous,Polymer Coated orChlorinated, PowderFree Nitrile | Ambidextrous,Polyacrylic PolymerInner Coating, PowderFree Nitrile | Similar |
| ColorDescription | - | - | Blue | Pink, Black | Different |
| Material | - | - | Mixture of Nitrile andChloroprene | Polychloroprene | Different |
| Single Use | - | - | Yes | Yes | Same |
| Packaging | - | - | Packed in DispenserBoxes | Packed in DispenserBoxes | Same |
| Characteristic | Standards | Related Defects | Subject DeviceChloropreneExaminationGloves PowderFree (Blue, Green)510(k) NumberK213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymerExaminationGloves, PowderFree BlackPolychloropreneCopolymerExaminationGloves, 510(k)Number K171743 | Remark |
| Dimension | |||||
| Length (size: XSmall),mm | ASTMD6977-19 | 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), mmThickness (finger), mm | 0.05 min0.05 min | Meet 0.05mm minMeet 0.05mm min | Meet 0.05mm minMeet 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) | ASTMD6977-19 | 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 | RelatedDefects | Subject DeviceChloropreneExaminationGloves PowderFree (Blue, Green)510(k) NumberK213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymerExaminationGloves, PowderFree BlackPolychloropreneCopolymerExaminationGloves, 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 D6977-19ASTM D6124-06 | Max.2mg/glove | Meet 2mg/glovemax. | Meet 2mg/glovemax | Similar |
| Biocompatibility Test | |||||
| i) Primary Skin IrritationTest | ISO 10993-10 | No AnimalIrritation | Passesi) Primary SkinIrritation Test.Conclusion: Underthe conditions of thisstudy the testmaterial did notcause an irritantresponse | Passesi)Primary SkinIrritation Test.Conclusion: Underthe conditions ofthe study, not anirritant | Same |
| ii)Skin SensitizationTest | ISO 10993-10 | No AnimalIrritation | ii)DermalSensitizationTest.Conclusion: Underthe conditions of thisstudy, the testmaterial did notproduce a skinsensitization effect | ii)DermalSensitizationTest.Conclusion: Underthe conditions ofthe study, not asensitizer | Same |
| Characteristic | Standards | RelatedDefects | Subject DeviceChloropreneExaminationGloves PowderFree (Blue, Green)510(k) NumberK213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymerExaminationGloves, PowderFree BlackPolychloropreneCopolymerExaminationGloves, 510(k)Number K171743 | Remark |
| Biocompatibility Test | - | ||||
| iii) In Vitro Cytotoxicity | ISO 10993-5 | - | iii) In VitroCytotoxicity Test.Conclusion:Under the conditionsof this study, the testmaterial exhibitedcytotoxicity responseat 100% of extractconcentration. | iii) No Information | Different |
| iv) Acute SystemicToxicity | ISO 10993-11 | - | iv) Acute SystemicToxicityConclusion:Under the conditionof this study, the testmaterial showed noadverse biologicalreaction afteradministration of thesample's extract onthe rats during theperiod of the study. | iv) No Information | Different |
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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
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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 DeviceChloropreneExaminationGloves PowderFree (Blue,Green) 510(k)Number K213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymer ExaminationGloves, Powder FreeBlack PolychloropreneCopolymer ExaminationGloves, 510(k) NumberK171743 | Remark |
|---|---|---|---|---|---|
| Product Code | - | - | LZA | LZA | Same |
| Intended Use | - | - | Intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner | Intended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner | Same |
| Design | - | - | Powder Free, Non-Sterile,Ambidextrous,Beaded Cuff | Powder Free, Non-Sterile,Ambidextrous, BeadedCuff | Same |
| Indications forUse | - | - | A patientexamination gloveis a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientand examiner | A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner | Same |
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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 DeviceChloropreneExaminationGloves PowderFree (Blue,Green) 510(k)NumberK213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymer ExaminationGloves, Powder FreeBlack PolychloropreneCopolymer ExaminationGloves, 510(k) NumberK171743 | Remark |
|---|---|---|---|---|---|
| Construction | - | - | Ambidextrous,Polymer Coatedor Chlorinated,Powder FreeNitrile | Ambidextrous, PolyacrylicPolymer Inner Coating,Powder Free Nitrile | Similar |
| ColorDescription | - | - | Green | Pink, Black | Different |
| Material | - | - | Mixture of Nitrileand Chloroprene | Polychloroprene | Different |
| Single Use | - | - | Yes | Yes | Same |
| Packaging | - | - | Packed inDispenser Boxes | Packed in Dispenser Boxes | Same |
| Characteristic | Standards | Related Defects | Subject DeviceChloropreneExaminationGloves Powder Free(Blue, Green) 510(k)Number K213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymerExamination Gloves,Powder Free BlackPolychloropreneCopolymerExamination Gloves,510(k) NumberK171743 | Remark |
| Dimension | |||||
| Length (size: XSmall),mm | ASTMD6977-19 | 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), mmThickness (finger), mm | 0.05 min0.05 min | Meet 0.05mm minMeet 0.05mm min | Meet 0.05mm minMeet 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) | ASTMD6977-19 | 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 DeviceChloropreneExaminationGloves PowderFree (Blue, Green)510(k) NumberK213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymerExaminationGloves, PowderFree BlackPolychloropreneCopolymerExaminationGloves, 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 D6977-19ASTM D6124-06 | Max.2mg/glove | Meet 2mg/glovemax. | Meet 2mg/glovemax | Similar |
| Biocompatibility Test | |||||
| i) Primary Skin IrritationTest | ISO 10993-10 | No AnimalIrritation | Passesi) Primary SkinIrritation Test.Conclusion: Underthe conditions of thisstudy the testmaterial did notcause an irritantresponse | Passesi)Primary SkinIrritation Test.Conclusion: Underthe conditions ofthe study, not anirritant | Same |
| ii)Skin SensitizationTest | ISO 10993-10 | No AnimalIrritation | ii)DermalSensitizationTest.Conclusion: Underthe conditions of thisstudy, the testmaterial did notproduce a skinsensitization effect | ii)DermalSensitizationTest.Conclusion: Underthe conditions ofthe study, not asensitizer | Same |
| Characteristic | Standards | RelatedDefects | Subject DeviceChloropreneExaminationGloves PowderFree (Blue, Green)510(k) NumberK213993 | Predicate DevicePowder Free PinkPolychloropreneCopolymerExaminationGloves, PowderFree BlackPolychloropreneCopolymerExaminationGloves, 510(k)Number K171743 | Remark |
| Biocompatibility Testiii) In Vitro Cytotoxicity | ISO 10993-5 | - | iii) In VitroCytotoxicity Test.Conclusion:Under the conditionsof this study, the testmaterial exhibitedcytotoxicity responseat 100% of extractconcentration. | iii) No Information | Different |
| iv) Acute SystemicToxicity | ISO 10993-11 | - | iv) Acute SystemicToxicityConclusion:Under the conditionof this study, the testmaterial showed noadverse biologicalreaction afteradministration of thesample's extract onthe rats during theperiod of the study. | iv) No Information | Different |
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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 D6977-19ASTM 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 Strength14 MPa min. | Ultimate Elongation500 % min. | Tensile Strength14 MPa min. | Ultimate Elongation400 % min. | ||||
| Residual Powder Content | ASTM D6977-19ASTM 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.
§ 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.