(71 days)
The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
Surgeon's Gloves or Surgical Gloves. Anatomical in shape. Hand Specific (Left or Right). Available in sizes 6, 6½, 7, 7½, 8, 8½, 9. Made from Natural Rubber Latex, Sulphur, Zinc Oxide, ZDEC, ZDBC, Titanium Dioxide, Antioxidant (Styrenated Phenol), and Absorbable Corn Starch. Designed to comply with the physical measurements of ASTM D 3577.
The provided document describes a 510(k) submission for Surgeon's Gloves (SUR-G GLOV®) and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI-based device. Therefore, many of the requested elements for an AI device study (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable and not present in this document.
However, the document does contain information regarding the performance characteristics of the gloves, which can be interpreted as acceptance criteria based on the ASTM D 3577 standard.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is compared against the ASTM D 3577 (91) standard. This standard serves as the acceptance criteria for various physical characteristics of surgeon's gloves.
| Characteristics | Acceptance Criteria (ASTM D 3577 (91)) | Reported Device Performance (SUR-G GLOV®) |
|---|---|---|
| Width Size | ||
| 6 | $76 \pm 6$ | $76 \pm 3$ |
| 6½ | $83 \pm 6$ | $83 \pm 3$ |
| 7 | $89 \pm 6$ | $90 \pm 3$ |
| 7½ | $95 \pm 6$ | $95 \pm 3$ |
| 8 | $102 \pm 6$ | $103 \pm 3$ |
| 8½ | $108 \pm 6$ | $109 \pm 3$ |
| 9 | $114 \pm 6$ | $115 \pm 3$ |
| Length (min) | 265 | 280 |
| Thickness | ||
| Palm mm | 0.10 | $0.21 \pm 0.02$ |
| Finger mm | 0.10 | $0.23 \pm 0.02$ |
| Cuff mm | 0.10 | $0.21 \pm 0.02$ |
| Tensile Strength Min | ||
| (Unaged) | 24 Mpa | 27 Mpa |
| (Aged) | 18 Mpa | 24 Mpa |
| Elongation @ break | ||
| (Unaged) | 750% min | 830% |
| (Aged) | 560% min | 800% |
| Modulus @ 500 % elongation (max.) | 5.5 Mpa | 4.0 Mpa |
| External powder level | NA (Not Available in ASTM standard) | $80 \pm 25$ mg |
| Internal powder level | NA (Not Available in ASTM standard) | $90 \pm 25$ mg |
2. Sample sized used for the test set and the data provenance
The document states "A test certificate of the above is in Appendix B." but Appendix B is not provided in the extracted text. Therefore, the specific sample sizes used for testing these performance characteristics are not available. The data provenance (country of origin, retrospective/prospective) is also not available from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a physical device (surgical gloves), and its performance is measured against established engineering and material standards (ASTM D 3577), not by expert interpretation or ground truth derived from expert consensus.
4. Adjudication method for the test set
Not Applicable. As per point 3, the assessment is against a standard, not 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-based device, and therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is adherence to the ASTM D 3577 standard for surgical gloves, which defines acceptable physical properties.
8. The sample size for the training set
Not Applicable. This is not an AI device that requires a training set. The gloves are manufactured and tested against specifications.
9. How the ground truth for the training set was established
Not Applicable. No training set is relevant for this device. The "ground truth" (i.e., the standard specifications) for manufacturing and testing are established by ASTM International.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image is a black and white drawing of a compass rose. The compass rose has four points, each pointing in a different direction. The points are decorated with a stylized letter "H". The compass rose is symmetrical and has a simple design.
510(k) Submission for Surgeon's Gloves
JAN 2 9 1:98
510(k) Summary
| Applicant | Terang Nusa Sdn Bhd |
|---|---|
| Address | Lot E4(4), Jalan 8Pengkalan Chepa II FTZ16100 Kota BharuKelantan,Malaysia |
| Tel | + 60 (9) 773 5133 |
| Fax | + 60 (9) 773 7755 |
| Contact Person | LOW, Chin Guan (Managing Director)Nikolaus WEISS (QA Manager) |
| Summary prepared by | LOW, Chin Guan |
| Date | 15 July 1997 |
{1}------------------------------------------------
Image /page/1/Figure/0 description: The image shows a black and white compass rose. The compass rose has eight points, each representing a cardinal direction. The compass rose is a traditional symbol used on maps and charts to indicate direction. The image is simple and clear, making it easy to understand the basic design of a compass rose.
510(k) Submission for Surgeon's Gloves
Device Name 1.
| General Name : | Surgical GloveSurgeon's Glove |
|---|---|
| Proprietary Name : | SUR-G GLOV® |
| Classification : | Surgeon's Glove21 CFR Part 878.4460 |
| Classification Code : | 79 KGO |
Substantial Equivalence Comparison Product 2.
The device is compared to
| i) | Product | : | Triflex Surgeon's Glove |
|---|---|---|---|
| Manufactured by | : | Travenol Laboratories | |
| 510(k) | : | K832448 | |
| Classification | : | Surgeon's Glove | |
| : | 21 CFR Part 878.4460 | ||
| Quality Standard | : | ASTM D-3577 | |
| ii) | Product | : | Comfit Surgeon's Glove |
| Manufactured by | : | Wembley Rubber Products | |
| 510(k) | : | K903446 | |
| Classification | : | Surgeon's Glove | |
| : | 21 CFR Part 878.4460 | ||
| Quality Standard | : | ASTM D-3577 |
3. Intended Use of Device
The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
{2}------------------------------------------------
Image /page/2/Figure/0 description: The image shows a black and white drawing of a compass rose. The compass rose has eight points, with each point having a distinct shape. The drawing is simple and lacks shading or color variations.
Details of comparison data ( substantial equivalence ) 4.
| Areas of similarity | SUR-G GLOV® | TRIFLEX | COMFIT |
|---|---|---|---|
| Indications for Use | Yes | Yes | Yes |
| Design | Anatomical | Anatomical | Anatomical |
| Materials | Natural Latex | Natural Latex | Natural Latex |
| Performance | Per ASTM D3577 | Per ASTM D3577 | Per ASTM D3577 |
| Sterility | Yes | Yes | Yes |
| Biocompatibility | Yes | Yes | Yes |
| Physical properties | Per ASTM D3577 | Per ASTM D3577 | Per ASTM D3577 |
| Chemical Safety | Yes | Yes | Yes |
| Sterilization Method | Gamma Radiation | Gamma Radiation | Gamma Radiation |
| Compatibility of materialwith environment | Natural Rubber | Natural Rubber | Natural Rubber |
| Usage | Hospitals, Clinic,Ambulance | Hospitals, Clinic,Ambulance | Hospitals, Clinic.Ambulance |
| Nursing Homes | Nursing Homes | Nursing Homes | Nursing Homes |
| Standards met | ASTM D3577 | ASTM D3577 | ASTM D3577 |
| Shelf Life | 5 years | 5 years | 5 years |
| W.S. Protein < 120 µg/g | Yes | No | No |
{3}------------------------------------------------
Image /page/3/Figure/0 description: The image shows a black and white drawing of a compass rose. The compass rose has four points, each with a distinct shape. The design is simple and graphic, with clear lines and shapes.
510(k) Submission for Surgeon's Gloves
Design ડ.
The device is designed to comply with the physical measurements of ASTM D 3577.
| Product described as | Surgeon's Gloves or Surgical Gloves.Anatomical in shapeHand Specific (Left or Right) |
|---|---|
| Sizes available | 6 |
| 6½ | |
| 7 | |
| 7½ | |
| 8 | |
| 8½ | |
| 9 | |
| Product Specification | ASTM D 3577 (91) |
| EN 455 Part 1 & 2 (94) | |
| EN 552 (94) | |
| EN 556 (94) |
Material of Manufacture (Raw Materials) 6.
The following are the raw materials and chemical used in the manufacture of the product .
| Chemical Name | |
|---|---|
| Natural Rubber Latex | - |
| Sulphur | S |
| Zinc Oxide | ZnO |
| ZDEC | Zinc Diethyldithiocarbamate |
| ZDBC | Zinc Dibuthyldithiocarbamate |
| Titanium Dioxide | TiO2 |
| Antioxidant | Styrenated Phenol |
| Absorbable Corn Starch | - |
{4}------------------------------------------------
Image /page/4/Figure/0 description: The image shows a black and white compass rose. The compass rose has eight points, with the four cardinal directions being more prominent. The design is simple and stylized, with thick lines forming the shape of the compass rose. The image is clean and the compass rose is centered.
. . . . .
510(k) Submission for Surgeon's Gloves
7. Performance
| Characteristics | SUR-G GLOV® | ASTM D 3577 (91) |
|---|---|---|
| Width Size6 | $76 \pm 3$ | $76 \pm 6$ |
| 6½ | $83 \pm 3$ | $83 \pm 6$ |
| 7 | $90 \pm 3$ | $89 \pm 6$ |
| 7½ | $95 \pm 3$ | $95 \pm 6$ |
| 8 | $103 \pm 3$ | $102 \pm 6$ |
| 8½ | $109 \pm 3$ | $108 \pm 6$ |
| 9 | $115 \pm 3$ | $114 \pm 6$ |
| Length (min) | 280 | 265 |
| ThicknessPalm mm | $0.21 \pm 0.02$ | 0.10 |
| Finger mm | $0.23 \pm 0.02$ | 0.10 |
| Cuff mm | $0.21 \pm 0.02$ | 0.10 |
| Tensile Strength Min(Unaged) | 27 Mpa | 24 Mpa |
| (Aged) | 24 Mpa | 18 Mpa |
| Elongation @ break(Unaged) | 830% | 750% min |
| (Aged) | 800% | 560% min |
| Modulus @ 500 % elongation (max.) | 4.0 Mpa | 5.5 Mpa |
| External powder level | $80 \pm 25$ mg | NA |
| Internal powder level | $90 \pm 25$ mg | NA |
A test certificate of the above is in Appendix B.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like design with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.JAN 2 9 1998
Mr. Tony K. Djie ·President American Health Products, Incorporated 528 Amapola Avenue Torrance, California 90501-1215
Re : K974356 Trade Name: Surgeon's Gloves, Powdered, Latex, Sterile "Surq-G-Glov®" Regulatory Class: I Product Code: KGO Dated: December 31, 1997 Received: December 31, 1997
Dear Mr Djie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A -----substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission hoes
{6}------------------------------------------------
Page 2 - Mr. Djie
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy/A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image is a black and white drawing of a compass rose. The compass rose has four points, each with a sharp, triangular shape. The points are arranged in a circular pattern, with the north point at the top of the image. There are curved lines that are placed around the points of the compass rose.
510(k) Submission for Surgeon's Gloves
Indication for use Statement 3.
| Applicant | : | Terang Nusa Sdn Bhd |
|---|---|---|
| 510(k) Number | : | Not available |
| Device Name | : | Surgeon's Gloves |
| Trade Name | : | SUR-G GLOV® |
.
Indication for use
The surgeon's gloves are sterile gloves to be worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
Concurre.ice of CDHR Office of Device Evaluation (ODE)
Chin S. Lin
(Division Sign-Off Division of Dental, Infection Contr and General Ho 510(k) Number
Prescription Use Per 21 CFR 801.109 X
ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
§ 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).