(111 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of surgical gloves, with no mention of AI or ML technology.
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
The device description indicates that it is a sterile surgical glove intended to protect a surgical wound from contamination, which is a protective barrier function, not a diagnostic one.
No
The device description clearly states the device is made of natural rubber latex and is a physical glove, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier function for infection control during surgery.
- Device Description: The description focuses on the physical properties of the glove (material, sterility, size, protein content) and its function as a protective barrier.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to perform tests on samples like blood, urine, or tissue to gain diagnostic information. This surgical glove does not perform any such diagnostic function.
N/A
Intended Use / Indications for Use
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes.
All variants share the same natural color (No color is added).
The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted to verify that the proposed device met all design specifications and acceptance criteria found in the standards or test methodology. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-2019:- Standard Specification for Rubber Surgical Gloves.
ASTM D5151-2019:- Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (2017):- Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-15:- Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM F1929-2015:- Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10- Tests for irritation and skin sensitization.
ISO 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5-Tests for in vitro Cytotoxicity
ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11- Tests for Systemic Toxicity and Biological Tests
ISO 11137-1-2006/ (R) 2010 - validation of sterilization process
ISO 11137-2:2013, sterilization of health care products - radiation - part 2: Establishing the sterilization dose
USP 42 Bacterial Endotoxin Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length: Min 265mm
- Width: 76+/-6mm, 83+/-6mm, 89+/-6mm, 95+/-6mm, 102+/-6mm, 108+/-6mm, 114+/-6mm
- Finger Thickness: Min 0.10mm
- Palm Thickness: Min 0.10mm
- Cuff Thickness: Min 0.10mm
- Tensile Strength: Before aging 24Mpa minimum; After aging@ 70°±2C for 166±2 hr 18Mpa minimum
- Ultimate Elongation: Before aging 750% minimum; After aging@ 70°±2C for 166±2 hr 560% minimum
- Stress at 500% before ageing: 5.5 MPa Max
- Pinhole AQL: Max 1.5 (Before and After aging)
- Powder content:
§ 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 U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 27, 2021
Pentavest Holdings Sdn Bhd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, Illinois 60504
Re: K212848
Trade/Device Name: Sterile Latex Surgical Gloves Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: September 1, 2021 Received: September 7, 2021
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212848
Device Name
Sterile Latex Surgical Gloves powder free
Indications for Use (Describe)
Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be 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) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K212848 510K SUMMARY As required by: 21CFR § 807.92
A. APPLICANT INFORMATION
| 1. | Submitter Name | Pentavest Holdings Sdn Bhd |
|---|---|---|
| 2 | Date Submitted | 01 September 2021 |
| 3 | Address | No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian |
| Tangga, Batu , 76400 Melaka, Malaysia | ||
| 4 | Phone | +601 22332689 |
| 5 | Fax | ------- |
| 6 | bjteng@pentavest.com.my | |
| 7 | Contact Person | Teng Boon Joo |
| 8 | Designation | Managing Director |
| 9 | Contact Number | +601 22332689 |
| 10 | Contact Email | bjteng@pentavest.com.my |
B. US AGENT & CONTACT PERSON INFORMATION
| 11 | US agent &
contact person name | Manoj Zacharias |
|----|-----------------------------------|-----------------------------------------------------------------------------------|
| 12 | Address | Liberty Management Group Ltd.
75 Executive Dr. STE 114, Aurora, IL-60504, USA. |
| 13 | Phone | (630) 270-2921 |
| 14 | Fax | (815) 986-2632 |
| 15 | E-mail | manoj@libertymanagement.us |
C. DEVICE IDENTIFICATION
| 16 | Common Name | Surgical Gloves |
|---|---|---|
| 17 | Device Name | Sterile Latex Surgical Gloves Powder Free |
| Product proprietary or | ||
| trade name | George Glove | |
| 18 | Classification name | Surgeon's Gloves |
| 19 | Device Classification | 1 |
| 20 | Product Code | KGO |
| 21 | Regulation Number | 21 CFR 878.4460 |
| 22 | Review Panel | Gen & Plastic Surgery |
4
D. PREDICATE DEVICE INFORMATION
| Description | Name of device | 510k
Number | 510K Owner |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
device | JR Medic Latex Surgeon's Gloves
Sterile Powder Free with protein
content labeling claim of 50 µg/
dm² or less per glove of
extractable protein | K192328 | JR Engineering & Medical
Technologies (M) SDN.
BHD.
Lot 8 &10, Jalan Zurah 3
& Lot 1&3, Jalan Zurah
3A/1, Pusat Perindustrian
2, 44200 Rasa, Hulu
Selangor, Selangor Darul
Ehsan, Malaysia. |
E. DESCRIPTION OF THE DEVICE
The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves.
The classification is: Type I - gloves compounded primarily from natural rubber latex.
The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes.
All variants share the same natural color (No color is added).
The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
F. INDICATION FOR USE:
A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
5
G. TECHNOLOGICAL CHARACTERISTIC COMPARISON
| Characteristic | Subject device
K212848 | Predicate device
K192328 | Remarks | |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KGO | KGO | Same | |
| Regulation No. | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | |
| Class | 1 | 1 | Same | |
| Intended Use | A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | Similar | |
| Powdered or Powder free | Powder free | Powder free | Same | |
| Classification as per
ASTM D3577-2019,
Standard Specification
for Rubber Surgical
Gloves | Type I - gloves compounded primarily from natural rubber latex | Type I - gloves compounded primarily from natural rubber latex | Same | |
| Sterilization | Radiation,
SAL- 10-6 | ETO/as well as Radiation,
SAL- 10-6 | Similar | |
| Label and Labeling | Meet FDA's label
Requirements | Meet FDA's label
Requirements | Same | |
| Special label claim | Protein content labeling claim of 50µg/dm² or less per glove of extractable protein for Latex Surgeon's Gloves Powder Free. | Protein content labeling claim of 50µg/dm² or less per glove of extractable protein for Latex Surgeon's Gloves Powder Free. | Same | |
| Type of use | Over the counter use | Over the counter use | Same | |
| Characteristics | Acceptance criteria of the standard | | Remarks | |
| | Subject device
K212848 | Predicate device
K192328 | | |
| Dimensions
Length:- Min
265 mm | 380 mm | 300 mm | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves | |
| Size | | | | |
| 6.0 (76+/-6mm) | 74mm | 78mm | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves | |
| 6.5 (83+/-6mm) | 86mm | 85mm | | |
| 7.0 (89+/-6mm) | 92mm | 88mm | Standard Specification for Rubber | |
| 7.5 (95+/-6mm) | 98mm | 97mm | Surgical Gloves | |
| 8.0 (102+/6mm) | 105mm | 103mm | | |
| 8.5 (108+/6mm) | 110mm | 110mm | | |
| 9.0 (114+/6mm) | 116mm | 116mm | | |
| Cuff, Palm,
Finger Tip Min
0.10 mm | Cuff-
0.12mm
Palm-0.16mm
Finger Tip-
0.21mm | Cuff-
0.11mm
Palm-0.18mm
Finger Tip-
0.21mm | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves | |
| Tensile Strength
24Mpa minimum | 28.55Mpa | 26.0Mpa | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves | |
| Ultimate
Elongation
750% minimum | 870% | 860% | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves | |
| Stress at 500%
5.5 MPa Max | 5.1Mpa | 2.7 Mpa | | |
| Tensile Strength
18Mpa minimum | 23.48Mpa | 22.0Mpa | Similar
Meets ASTM D3577-2019,
Standard Specification for Rubber
Surgical Gloves | |
| Ultimate
Elongation
560% minimum | 731% | 725% | | |
| Characteristics | Acceptance criteria of the standard | | Remarks | |
| | Subject
device
K212848 | Predicate device
K192328 | | |
| Freedom from
Holes
AQL 1.5 | AQL 1.0 | AQL 1.0 | Similar
Meets ASTM D3577-2019 and
ASTM D5151-2019,
Standard Test Method for Detection
of Holes in Medical Gloves | |
| Powder residue
for powder free
glove Powder
content Pyrogen Test | ------ | Non pyrogenic | ------ |
| Systemic Toxicity | ISO 10993-11:2017(E)
,Biological Evaluation of
Medical Devices - Part
11, Tests for Systemic
Toxicity | Under the
conditions
of study the
device extracts do
not pose a
systemic toxicity
concern | No data available | ------ |
| Bacterial
Endotoxin | USP 42 | Bacterial Endotoxin Test
12
| Test
| Methodology/Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10 | |||
| Biological Evaluation of | |||
| Medical Devices Test | |||
| for Irritation and Skin | |||
| Sensitization. Test done | |||
| for irritation. | To determine the | ||
| potential of the | |||
| material under test to | |||
| produce dermal | |||
| irritation in Rabbits | Under the condition | ||
| of study not an | |||
| irritant | Under the condition | ||
| of study not an | |||
| irritant | |||
| ISO 10993-10 | |||
| Biological Evaluation of | |||
| Medical Devices Test | |||
| for Irritation and Skin | |||
| Sensitization. Test done | |||
| Skin sensitization. | To determine the skin | ||
| sensitization potential | |||
| of the material both in | |||
| terms of induction | |||
| and elicitation in | |||
| Guinea Pig. | Under the conditions | ||
| of the study not a | |||
| sensitizer | Under the conditions | ||
| of the study not a | |||
| sensitizer | |||
| ISO 10993-5:2009 | |||
| biological evaluation of | |||
| medical devices - part 5, | |||
| tests for in vitro | |||
| cytotoxicity. | To evaluate the in | ||
| vitro cytotoxic | |||
| potential of the test | |||
| item (both inner and | |||
| outer surface) | |||
| Extracts in L-929 | |||
| mouse fibroblasts | |||
| cells using elution | |||
| method. | Under the conditions | ||
| of study non | |||
| cytotoxic | Under the conditions | ||
| of the study | |||
| cytotoxic. | |||
| ISO 10993-11:2017 | |||
| biological evaluation of | |||
| medical devices - part | |||
| 11, tests for systemic | |||
| toxicity. | To determine the | ||
| acute systemic | |||
| toxicity potential of | |||
| the test item extracts | |||
| (both inside and outer | |||
| surfaces) in Swiss | |||
| Albino mice. | Under the conditions | ||
| of study the device | |||
| extracts do not pose a | |||
| systemic toxicity | |||
| concern | Under the conditions | ||
| of study the device | |||
| extracts do not pose a | |||
| systemic toxicity | |||
| concern | |||
| USP 42 | Bacterial Endotoxin | ||
| Test |