(78 days)
Not Found
Not Found
No
The summary describes standard surgical gloves and their performance testing, with no mention of AI or ML.
No
The device is a surgical glove intended for protection and sterility during medical procedures, not for treating or curing a medical condition.
No
Explanation: The device is surgical gloves used for protection, not for diagnosing medical conditions. The provided information focuses on the glove's physical properties and safety, not on diagnostic capabilities or outputs.
No
The device is a physical product (surgical gloves) and the summary describes material composition and physical performance testing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these gloves are for use by operating room personnel to protect a surgical wound from contamination. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the materials and form of the gloves, which are physical barriers.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties of the gloves (toxicity, reactivity, strength, barrier integrity, powder level), which are relevant to their function as a protective barrier. They do not involve any diagnostic performance metrics.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Coated Sterile Latex Powder-Free Surgical Gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are 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
Coated Sterile Latex Powder-free Surgical gloves are formulated using natural rubber latex and are coated with a nitrile coating. These are offered powder-free and sterile.
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 / hospitals and other healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Testing:
Systemic Toxicity - Gloves do not elicit any toxic reactions to acute application.
Intracutaneous Reactivity - Gloves show no reactivity.
Guinea Pig Maximization - Gloves do not display any potential for irritation.
Ultimate Elongation & Tensile Strength - Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-99.
Barrier Defects - Gloves exceed requirements per 21 CFR §800.20, AQL = 2.5.
Data/Test Method - Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 4 mg of residual powder per glove.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ultrafree Sterile Latex Powder-Free Surgical Gloves
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
队99217/
XIV. SUMMARY OF SAFETY AND EFFECTIVENESS
Allegiance
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES
| Manufacturer: | Allegiance Healthcare Sdn. Bhd.
Plot 87, Kampung Jawa
11900 Bayan Lepas
Penang, West Malaysia |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: Erica Sethi | Allegiance Healthcare Corporation
1500 Waukegan Road, MP-WM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3337 |
| Date Summary Prepared: | 6/16/99 |
| Product Trade Name: | Undetermined |
| Common Name: | Surgical Glove |
| Classification: | Glove, Surgeon's |
| Predicate Devices: | Ultrafree Sterile Latex Powder-Free Surgical Gloves |
| Description: | Coated Sterile Latex Powder-free Surgical gloves are formulated
using natural rubber latex and are coated with a nitrile coating.
These are offered powder-free and sterile. |
| Intended Use: | Coated Sterile Latex Powder-Free Surgical Gloves are
intended for use in environments within hospitals and other
healthcare facilities. The gloves are appropriate for use during
invasive and non-invasive medical procedures requiring sterility.
They are intended to be worn by operating room personnel to
protect a surgical wound from contamination. |
1
| Substantial Equivalence: | Coated Sterile Latex Powder-Free Surgical Gloves are substantially equivalent to Ultrafree Sterile Latex Powder-Free Surgical Gloves in that they provide the following characteristics:
- same intended use
- same sizes, configuration, packaging
- both made of natural rubber latex
- same tensile strength and thickness profiles |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Testing: | |
| Test | Result |
| Systemic Toxicity | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | Gloves show no reactivity. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Ultimate Elongation
& Tensile Strength | Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-99. |
| Barrier Defects | Gloves exceed requirements per 21 CFR
§800.20, AQL = 2.5. |
| Data/Test Method | Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97-Standard test method for residual powder on medical gloves. Results generated values below 4 mg of residual powder per glove. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service". The text is in a bold, sans-serif font. The words are arranged on a single line.
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SED 1 4 1999
Ms. Erica Sethi Manager, Regulatory Affairs Alleqiance Healthcare Corporation 1500 Waukeqan Road McGaw Park, Illinois 60085
Re : K992171 Coated Sterile Latex Powder-Free Surgical Trade Name: Gloves with Protein Content Labeling Claim (50 micrograms or less) Requlatory Class: · 4 · Product Code: KGO Dated: August 18, 1999 Received: August 19, 1999
Dear Ms. Sethi:
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 aqainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Page 2 -Ms. Sethi
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 described in your sia equivalence of your device to a legally marketed predicate device results in a classification for your marketed production of mits 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) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact che Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to che regulation chercica) Missions 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,
Timbthy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '992171'. The numbers are written in a simple, slightly slanted style, and the image is in black and white.
Image /page/4/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is in black and the background is white. The font is slightly slanted to the right.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
Page 1 of 1
| Applicant: | Allegiance Healthcare Corporation |
|---|---|
| 510(k) Number: | |
| Device Name: | Coated Sterile Latex Powder-Free Surgical Gloves |
| With Protein Content Labeling Claim (50 micrograms or less) | |
| Indications For Use: | These gloves are intended for use in environments within hospitals |
| and other healthcare facilities. The gloves are appropriate for use during | |
| invasive as well as non-invasive medical procedures requiring sterility. | |
| They are intended to be worn by operating room personnel to protect a | |
| surgical wound from contamination. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | or Over-The Counter Use ✓ |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K992171 |