(327 days)
No
The device is a surgical glove and the description focuses on its material and manufacturing process, with no mention of AI or ML.
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or directly manage a disease or condition.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device description clearly identifies the device as a physical product (sterile latex surgical glove) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Intended Use: The intended use of this device is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier device used on the body (or to protect something on the body), not to perform a diagnostic test on a sample.
- Device Description: The description focuses on the physical characteristics and manufacturing process of a glove, not on any diagnostic testing capabilities.
- Lack of Diagnostic Elements: The document does not mention any of the typical elements associated with IVDs, such as:
- Analyzing biological samples
- Detecting analytes (substances in the body)
- Providing diagnostic information
- Using reagents or test kits
This device is a medical device, specifically a surgical glove, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
The subject device is a powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
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
Testing performed as per ASTM D3577-15, Standard Specification for Rubber Surgical Gloves, and 21 CFR 878.4460. The subject device meets all the ASTM D3577-15 requirements. Non-clinical laboratory and animal-based tests indicate that the sterile latex surgical glove, powder free meets all the performance and biocompatibility requirements for the referenced standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 30, 2019
Careglove Global Sdn Bhd Lim Shyan Managing Director Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban, 70450 My
Re: K190241
Trade/Device Name: Sterile Latex Surgical Glove, Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: November 8, 2019 Received: November 12, 2019
Dear Lim 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.
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
1
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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190241
Device Name
STERILE LATEX SURGICAL GLOVES, POWDER FREE
Indications for Use (Describe)
A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
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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FORM FDA 3881 (7/17)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large, blue, sans-serif font. Below that, the word "GLOVE" is in a smaller, yellow, sans-serif font. In the middle of the word "GLOVE" is a blue circle with a yellow hand in the center. Below that, the words "CAREPLUS-DESCARPACK" are in a small, black, sans-serif font.
OVE GLO
orong Senawang 3/2, Off Jalan Senaw vang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. 82377, 60-6-6788377 Fax: 60-6-6785377 @careelove.com
K190241
510(K) SUMMARY
CAREGLOVE GLOBAL SDN BHD Applicant:
- Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
- Fax No. (60) 66785377 Phone No. (60) 6 6782377
Contact Person: Lim Kwee Shyan
Summary Preparation Date: 23rd December, 2019
Device Information
| Trade Name: | STERILE LATEX SURGICAL GLOVES, POWDER FREE |
|---|---|
| Common Name: | STERILE LATEX SURGICAL GLOVES, POWDER FREE |
| Classification Name: | Surgeon's Gloves |
| Product Code: | KGO |
| Regulation: | 21 CFR 878.4460 |
| Device Class: | I |
Predicate device
Device Name: STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
Company name: SUPERMAX GLOVE MANUFACTURING SDN BHD
510(K) Number: K014230
Device Description
The subject device is a powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
Indication for Use
A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
4
Image /page/4/Picture/0 description: The image shows the logo for "CARE GLOVE" in a stacked format. The word "CARE" is in a larger, blue font on top, while "GLOVE" is in a smaller, yellow font below it. A hand graphic is placed within the word "GLOVE". The text "CAREPLUS-DESCARPACK" is at the bottom in a smaller, sans-serif font.
CAREGLOVE GLOBAL S
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
Summary of the Technological Characteristics of the Device
Table 1: Comparison of the Technological Characteristics of the Subject and Predicate Device.
| Characteristic | Standard | Specification | Subject Device
Sterile Latex
Surgical Powder
Free
K190241 | Legally Marketed
Predicate Device
K014230 | Remark |
|-------------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | - | - | KGO | KGO | Same |
| Indication for Use
Statement | - | - | A sterile latex
surgical glove,
powder free is a
disposable device
intended for medical
purposes that is worn
by operating room
personnel to protect
a surgical wound
from contamination. | A sterile latex surgical
glove, powder free is a
disposable device
intended for medical
purposes that is worn
by operating room
personnel to protect a
surgical wound from
contamination. | Same |
| Design | - | - | Powder Free, Sterile,
Hand Specific,
Beaded Cuff | Powder Free, Sterile,
Hand Specific, Beaded
Cuff | Same |
| Construction | - | - | Hand Specific,
Polymer Coated or
Chlorinated, Latex
Surgical Gloves,
Powder Free | Hand Specific, Polymer
Coated or Chlorinated,
Latex Surgical Gloves,
Powder Free with
Protein Claim (50
Microgram or less Per
Gram of Gloves) | Similar |
| Color Information | - | - | Natural | Natural | Same |
| Material | - | | Natural Rubber | Natural Rubber | Same |
| Single Use | - | - | Yes | Yes | Same |
| Sterility | ISO
11737-2 | - | Sterile | Sterile | Same |
| Sterilization Method | - | - | Gamma Irradiation | Gamma Irradiation | Same |
| Packaging | - | - | Packed in Pouches | Packed in Pouches | Same |
| Table 2: Summary of the Non-Clinical Testing for the Subject Device and Comparison to the Predicate Device. | | | | | |
| Characteristic | Standard | Specification | Subject Device
Sterile Latex
Surgical Powder
Free
K190241 | Legally Marketed
Predicate Device
K014230 | Remark |
| Dimension | ASTM
D3577-
15 | | | | |
| Length (size: 5.5), mm | | 245 min | Meet 245mm min | Meet 245mm min | Same |
| Length (size: 6.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | |
| Length (size: 6.5), mm | | 265 min | Meet 265mm min | Meet 265mm min | |
| Length (size: 7.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | |
| Length (size: 7.5), mm | | 265 min | Meet 265mm min | Meet 265mm min | |
| Length (size: 8.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | |
| Length (size: 8.5), mm | | 265 min | Meet 265mm min | Meet 265mm min | |
| Length (size: 9.0), mm | | 265 min | Meet 265mm min | Meet 265mm min | |
| Thickness (cuff), mm | | 0.10 min | Meet 0.10mm min | Meet 0.10mm min | Same |
| Thickness (palm), mm | | 0.10 min | Meet 0.10mm min | Meet 0.10mm min | |
| Thickness (finger), mm | | 0.10 min | Meet 0.10mm min | Meet 0.10mm min | |
| Width (size: 5.5), mm | | $70 \pm 6$ | Meet $70 \pm 6$ mm | Meet $70 \pm 6$ mm | |
| Width (size: 6.0), mm | | $76 \pm 6$ | Meet $76 \pm 6$ mm | Meet $76 \pm 6$ mm | |
| Width (size: 6.5), mm | | $83 \pm 6$ | Meet $83 \pm 6$ mm | Meet $83 \pm 6$ mm | Same |
| Width (size: 7.0), mm | | $89 \pm 6$ | Meet $89 \pm 6$ mm | Meet $89 \pm 6$ mm | |
| Width (size: 7.5), mm | | $95 \pm 6$ | Meet $95 \pm 6$ mm | Meet $95 \pm 6$ mm | |
| Width (size: 8.0), mm | | $102 \pm 6$ | Meet $102 \pm 6$ mm | Meet $102 \pm 6$ mm | |
| Width (size: 8.5), mm | | $108 \pm 6$ | Meet $108 \pm 6$ mm | Meet $108 \pm 6$ mm | |
| Width (size: 9.0), mm | | $114 \pm 6$ | Meet $114 \pm 6$ mm | Meet $114 \pm 6$ mm | |
| Water Leak Test,
1000 ml | ASTM
D3577-
15 ASTM
D5151-
06 | | | | Same |
| Before Aging, AQL | | G- I, AQL 1.5
(FDA GII, AQL
1.5) | Meet AQL 1.5 | Meet AQL 1.5 | |
| After Aging, AQL | | | Meet AQL 1.5 | Meet AQL 1.5 | |
| Physical Properties | ASTM
D3577-
15 | | | | |
| (Before Ageing)
i) TensileStrength
(MPa) | | Min. 24 | Meet 24MPa min. | Meet 24MPa min. | Similar |
| ii) Ultimate Elongation
(%) | | Min. 750 | Meet 750% min | Meet 750% min | |
| ii) Stress at 500%
Elongation (MPa) | | Max. 5.5 | Meet 5.5 MPa max | Meet 5.5 MPa max | |
| (After Aging)
i) Tensile Strength
(MPa) | | Min. 18 | Meets 18MPa min | Meets 18MPa min | |
| ii) Ultimate Elongation
(%) | | Min. 560 | Meet 560% min. | Meet 560% min. | |
| Characteristic | Standard | Specification | Subject Device
Sterile Latex
Surgical Powder
Free
K190241 | Legally Marketed
Predicate Device
K014230 | Remark |
| Residual
Powder
Content | ASTM
D3577-15
ASTM
D6124-06 | Max.
2mg/glove | Meet 2mg/glove max. | Meet 2mg/glove max | Similar |
| Residual
Powder
Content, mg/glove | | | | | |
| Extractable
Protein
Content | ASTM
D5712-10 | 50 µg/dm²
and below | Meet Specification | 50 µg/dm² and below | Similar |
| Water Extractable
Protein Content,
µg/dm² | | | | | |
| 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 this study
the test material did not
cause an
irritant
response. | Same |
| ii) Skin Sensitization
Test | ISO 10993-
10 | No Animal
Sensitization | 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 this study,
the test material did not
produce a skin
sensitization effect | Same |
| iii) Cytotoxicity Test | ISO 10995-
5 | Non-
cytotoxicity | moderate-cytotoxicity
at 6 cm²/mL
extraction | Data not available from
manufacture | Different |
| iv) Acute Toxicity Oral | ISO 10993-
11 | No toxic | No adverse biological
reaction | Data not available from
manufacture | Different |
| v) Pyrogenic Test | USP
General
Chapter
40, | Non
pyrogenic | Non pyrogenic | Data not available from
manufacture | Different |
Summary of Non-Clinical Testing
Testing performed as per ASTM D3577-15, Standard Specification for Rubber Surgical Gloves, and 21 CFR 878.4460. The subject device meets all the ASTM D3577-15 requirements. The table below summarizes the non-clinical tests performed and the standards used in this submission.
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Image /page/5/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large blue letters on top of the word "GLOVE" which is in a light yellow color. In the middle of the word "GLOVE" is a blue circle with a light yellow hand in the center. Below the word "GLOVE" is the text "CAREPLUS-DESCARPACK".
CAREGLOVE GLOBAL SDN B
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
6
Image /page/6/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large blue letters on top of the word "GLOVE" in smaller yellow letters. A hand is in the middle of the word "GLOVE". The words "CAREPLUS-DESCARPACK" are in small blue letters at the bottom.
CAREGLOVE GLOBAL SD
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
Non-clinical laboratory and animal-based tests indicate that the sterile latex surgical glove, powder free meets all the performance and biocompatibility requirements for the referenced standards.
7
Image /page/7/Picture/0 description: The image shows a logo with the words "CARE GLOVE" stacked on top of each other. The word "CARE" is in blue, and the word "GLOVE" is in yellow, with a yellow hand in the middle of the word. Below the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in a smaller font size.
CAREGLOVE GLOBAL SD
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com
Summary of Clinical Testing
Not applicable.
Conclusions: The conclusions drawn from nonclinical tests demonstrate that the subject device (K190241) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K014230.