(183 days)
Not Found
No
The device description and performance studies focus on material properties and barrier protection, with no mention of AI or ML.
No.
The device is described as a sterile cover garment for operating room procedures, designed to protect personnel rather than to treat or diagnose a medical condition.
No
The device is an O.R. gown intended as a sterile cover garment during surgical procedures, not for identifying or diagnosing a condition or disease.
No
The device description clearly states it is a physical gown made of SMS non-woven material with reinforced areas, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "sterile cover garment" for use in operating room procedures. This is a physical barrier for protection, not a test performed on samples taken from the human body.
- Device Description: The description details the materials and construction of a gown, not reagents, instruments, or software used for diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The performance studies mentioned relate to the physical properties of the gown (blood and viral penetration, flammability, biocompatibility), which are relevant to its function as a protective barrier, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is a sterile, single use, disposable garment to be used during surgical procedures in the operating room to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment.
Product codes
FYA
Device Description
The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.
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 / operating room
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)
The material used in the manufacture of the UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves was tested in accordance with applicable standards and was determined to pass the Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood ASTM F1670-98 and the Viral Penetration testing, ASTM F1671-97b in the reinforced gown areas. The material was tested in accordance with the National Fire Protection Association No. 702-1980, "Wearing Apparel Flammability" and meets Class 1. These devices meet the requirements for biocompatibility per ISO 10993 for surface devices, intact skin, limited duration (
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
MAY 2 2 2002
SMDA REQUIREMENTS 510(k)
2013846
SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE UltraGard™ IMPERVIOUS REINFORCED GOWN
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
| Submitter's Name: Precept Medical Products, Inc. | |
|---|---|
| 370 Airport Road | |
| Arden, North Carolina 28704 USA | |
| Telephone: (828) 681-0209 |
Mary Ann Faulkner, V. P. Quality Assurance/Regulatory Affairs Contact Person:
Date of Summary: April 19, 2002
Device Name: UltraGard™ Blue Operating Room Gown with Impervious Reinforced Chest and Sleeves.
Device Classification: The legally marketed device has been classified as follows: Surgical gown drape and drape accessories; (79 FPH); 21 CFR § 878.4040.
Legally Marketed Devices To Which Equivalence Is Claimed: The legally marketed predicate device is the Kimberly-Clark ULTRA Zoned-Impervious Gown (K842115), determined to be substantially equivalent to a legally marketed device on June 11, 1984. The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is substantially equivalent to the Kimberly-Clark ULTRA Zoned-Impervious Gown in the intended use and in the performance attributes.
Device Description: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is composed of a single base layer of SMS non-woven material with reinforced areas of the chest and sleeves. The reinforced area contains an additional layer of polyester laminated to a film.
Intended Use: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is a sterile, single use, disposable garment to be used during surgical procedures in the operating room to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Descriptive Summary Of Technological Characteristics And Those Of Predicate Device: The UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is made of a composite of multiple layers of nonwoven material similar to the Kimberly-Clark ULTRA Zoned-Impervious Gown.
Performance Data: The material used in the manufacture of the UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves was tested in accordance with applicable standards and was determined to pass the Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood ASTM F1670-98 and the Viral Penetration testing, ASTM
1
F1671-97b in the reinforced gown areas. The material was tested in accordance with the National Fire Protection Association No. 702-1980, "Wearing Apparel Flammability" and meets Class 1. These devices meet the requirements for biocompatibility per ISO 10993 for surface devices, intact skin, limited duration (